Information Notice 1998-09, Collapse of an Isocam II, Dual-Headed Nuclear Medicine Gamma Camera

Collapse of an Isocam II, Dual-Headed Nuclear Medicine Gamma Camera

ML031050259
Person / Time
Site:	Beaver Valley, Millstone, Hatch, Monticello, Calvert Cliffs, Dresden, Davis Besse, Peach Bottom, Browns Ferry, Salem, Oconee, Mcguire, Nine Mile Point, Palisades, Palo Verde, Perry, Indian Point, Fermi, Kewaunee, Catawba, Harris, Wolf Creek, Saint Lucie, Point Beach, Oyster Creek, Watts Bar, Hope Creek, Grand Gulf, Cooper, Sequoyah, Byron, Pilgrim, Arkansas Nuclear, Three Mile Island, Braidwood, Susquehanna, Summer, Prairie Island, Columbia, Seabrook, Brunswick, Surry, Limerick, North Anna, Turkey Point, River Bend, Vermont Yankee, Crystal River, Haddam Neck, Ginna, Diablo Canyon, Callaway, Vogtle, Waterford, Duane Arnold, Farley, Robinson, Clinton, South Texas, San Onofre, Cook, Comanche Peak, Yankee Rowe, Maine Yankee, Quad Cities, Humboldt Bay, La Crosse, Big Rock Point, Rancho Seco, Zion, Midland, Bellefonte, Fort Calhoun, FitzPatrick, McGuire, LaSalle, Fort Saint Vrain, Shoreham, Satsop, Trojan, Atlantic Nuclear Power Plant
Issue date:	03/05/1998
From:	Cool D Office of Nuclear Material Safety and Safeguards
To:
References
IN-98-009, NUDOCS 9802270150
Download: ML031050259 (8)

I

Jim me-1411ht

.~Zi.

UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS

WASHINGTON, D.C. 20555 March 5, 1998 NRC INFORMATION NOTICE 98-09: COLLAPSE OF AN ISOCAM II, DUAL-HEADED

NUCLEAR MEDICINE GAMMA CAMERA

Addressees

All medical licensees.

Purpose

The U.S. Nuclear Regulatory Commission is issuing this information notice to alert addressees

to the occurrence of an incident involving an Isocam II, dual-headed nuclearv medicine gamma

camera, manufactured by Park Medical Systems of Quebec, Canada. The reported failure

mode under investigation poses a potential for a serious crushing injury to the patient or the

technicians using the camera. It is expected that recipients will review the information for

applicability to their facilities and consider actions, as appropriate, to ensure safety. However, suggestions contained in this information notice are not NRC requirements; therefore, no

specific action nor written response is required.

Description of Circumstances

The Food and Drug Administration (FDA) issued a Safety Notice on February 13, 1998, to alert

users of Isocam I single-head and Isocam 11dual-headed nuclear medicine gamma camera

systems of a possible design or manufacturing defect that could, cause structured failure and

result in serious injury to the patient undergoing testing, or to other personnel using or servicing

the camera. The FDA Notice is attached for your information. As indicated in that notice, Park

Medical Systems of Quebec, Canada, is no longer in business and, for this reason, owners of

such cameras are asked to report any malfunctions that could cause injury directly to the FDA.

Owners are also urged to notify FDA of their possession of such a camera so that FDA may

forward additional information on the camera as it becomes available.

The device is a radiation detector used to take images of patients injected with

radiopharmaceuticals. It contains no radioactive material. The hazard involves physical injury

from falling components, not radiation exposure.

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IN 98-09 March 5, 1998 This information notice requires no specific action or written response. If you have any

questions about the information in this notice, please-contact the technical contact listed below.

Donald A. Cool, Dire r

Divisionrof Industri ald

Medical Nuclear Safety

Office of Nuclear Material Safety

ahd Safeguards

Steven Baggett, NMSS

301-413-7273 E-mail: slb@nrc.gov

Attachments:

i. Food and Drug Administration Safety Notice

2. List of Recently Issued NMSS Information Notices

3. List of Recently Issued NRC Information Notices

Attachment 1 V-/ 'IN 98-09 March 5, 1998 ]DEPARTMENT OF HEALTH & HUMAN SERVICES Pubic Health Service

Fod mid Drug Administration

FEF . 3 Rockve MD 208 FDA Safety Notice

Fiilure of Isocam [I, Daln-Headed Nulear Medicine Gamma Camker

TO: Nuclear Medicine maging Faities

FDA has recently become aware of a malfunction, with potential for serious injury, involving

an Isocarm I, dua- nuc medicne gamma camera (also aailable as a single- head system), manuicturd by Park Medical Systems of Quebec, Canada. A stainless steel

plate from a harmonic drive mootor Ez1ed causing an arm of the system to fall into the gantry

housing of the device- No colfirarorws on the camer at the iimc and no patient or

operator was injured.

The cause of this incident is under stigation by the UK., Medical Devices Agency and

Park U.K. We will report the findings once they become known; but we are unable to offer

any recommendation at this time.

Adverse event eepbrts rlated to device malunctions that could cause or contribute to a

serious injury are usully submitted to the device manufcr. s Park Medical Systems is

no longer in business, adverse event reports on the Isocam II camera should be submited to

FDA. In addition, if you own or operate one of these systems, please notify the FDA, at the

address below, so ha we can forward new information to you.

Please also be advised that the Safe Medical Devices Act of 1990 (SMDA) requires hospitals

and other user facilities to report deaths and serious illnesses and injuries associated with the

use of medical devices. Practitioners should follow the procedures established by their fility

for such mandatory reporvti

We encourage you to report directly to MNeWax-, FDA's volunay reporting program, those problems and malfunctions not required to be reported under SMDA. You mnay report

to MedWatch by phone at 1480-FDA-1088; by FAX at 1400-FDA-0178; or by mail to

MedWatch, Food and Drug ri5si, i600 Fishers Lane (HE:-), Ro&cville, MD 20857.

If you own or operate one of these system or if you hire questions about the content of this

letter, please contact Paula Simenaue, CD , HFZ-510, 1350 Piccard Drive, Rocklle,, MD

20850, FAX 301-594-2968, or e-mail pzs hcd a v.

Sincerely yours, D. Bruce Burington, M.D.

D'c

Center for Devices and

Radiological Health

Attachment 2 IN 98-09 March 5, 1998 LIST OF RECENTLY ISSUED

NMSS INFORMATION NOTICES

Information Date of

Notice No. Subject Issuance Issued to

Information Likely to be Requested 313198 70, 72 and 76 All parts 30,40,cerun

98-08 lienee an w nuluwb

if an Emergency is Declared licensees ana cerincate hosedwt

required to have a Nuclear

Regulatory Commission approved

Emergency plan.

98-06 Unauthorized use of License 2/19/98 All NRC Licensees authorized

to Obtain Radioactive Materials, to Possess Licensed Materials

and its Implications Under The

Exparded Title 18 of the U.S. Cod

98-04 1997 Enforcement Sanctions for 2/9/98 All U.S. Nuclear Regulatory

Deliberate Violations of NRC Commission licensees.

Employee Protection

Requirements

98-01 Thefts of Portable Gauges 1/15198 All portable gauge licensees

97-91 Recent Failures of Control 12/31/97 All industrial radiography

Cables Used on Amersham licensees

Model 660 Posilock Radiography

Systems

97-89 Distribution of Sources and 12/29/97 All sealed source and device

Devices Without AuLnorization manufacturers and distributors

Second Retrofit to Industrial 12112/97 All Industrial radiography

97-87 Nuclear Company IR100 licensees

Radiography Camera, to

Correct Inconsistency in

10 CFR Part 34 Compatibility

97-86 Additional Controls for Transport 12/12/97 Registered users of the Model

of the Amersham Model No. 660 No. 660 series packages, and

Series Radiographic Exposure Nuclear Regulatory Commission

Devices industrial radiography licensees

97-75 Enforcement Sanctions Issued 09/24/97 All U.S. Nuclear Regulatory

as a Result of Deliberate Commission licensees

Violations of NRC Requirements

Attachment 3 IN 98-09 March 5,1998 LIST OF RECENTLY ISSUED

NRC INFORMATION NOTICES

Information Date of

Notice No. Subject Issuance Issued to

98-07 Offsite Power Reliability 2127198 All holders of operating licensees

Challenges from Industry for nuclear power reactors

Deregulation

98-06 Unauthorized Use of License to 2/19/98 All NRC licensees authorized to

Obtain Radioactive Materials, possess licensed material

And Its Implications Under The

Expanded Title 18 of the

U.S. Code

97-45, Supp. I Environmental Qualification 2/17/98 All holders of operating

Deficiency for Cables and licenses for nuclear power

Containment Penetration reactors except those licensees

Pigtails who have permanently ceased

operations and have certified that

the fuel has been permanently

removed from the reactor vessel

98-05 Criminal History Record 2/11/98 All holders of operating

Information licenses for power reactors

98-04 1997 Enforcement Sanctions for 219/98 All U.S. Nuclear Regulatory

deliberate Violations of NRC Commission licensees

Employee Protection requirements

98-03 Inadequate Verification of 1/21198 All holders of operating licenses

.Overcurrent Trip Setpoints in for nuclear power reactors

Metal-Clad, Low-Voltage

Circuit Breakers

98-02 Nuclear Power Plant Cold 1/21/98 All holders of operating licenses

Weather Problems and for nuclear power reactors

Protective Measures

9841 Thefts of Portable Gauges 1/15198 All portable gauge licensees

OL = Operating License

CP = Construction Permit

IN 98-09 March 5, 1998 This information notice requires no specific action or written response. If you have any

questions about the information in this notice, please contact the technical contact listed below.

0dghal8bW DOMtd A. %oaf

Donald A. Cool, Director, Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Steven Baggett, NMSS

301-415-7273 E-mail: slb@nrc.gov

Attachments:

1. Food and Drug Administration Safety Notice

2. List of Recently Issued NMSS Information Notices

3. List of Recently Issued NRC Information Notices

DOCUMENT NAME: P:%ISO-IN.WPD

To receive a copy of thds document, hilcate I the box: 'C - Copy without sttachmentlenclosure E - Copy with attachment/enclosure N - No copy

OFFICE MSB* MSB* Tech Ed* IMOB* IMNS

NAME SBaggett LCamper EKraus - via fax a fa x o

DATE 2/25/98 2/25/98 2/25/98 2125/98 2/26/98 OFFICIAL RECORD COPY

2 IN 98- March _, 1998 This information notice requires no specific action or written response. If you have any

questions about the information in this notice, please contact the technical contact listed below.

Donald A. Cool, Director, Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Steven Baggett, NMSS

301-415-7273 E-mail: sIb~nrc.gov

Attachments:

1. Food and Drug Administration Safety Notice

2. List of Recently Issued NMSS Information Notices

3. List of Recently Issued NRC Information Notices

DOCUMENT NAME: H:XTRACI\ISO-IN.WPD

To receive a copy of this document,. hlicate hI the box: C - Copy without atnchmentlenclosure 'E - Copy h enlosure N - No copy

OFFICE MSB* MSB* Tech Ed* I0IM

NAME SBaggett LCamper EKraus - via fax F m / D

DATE 2125/98 2125/98 2125198 ZW 9r AW098 OFFICIAL RECORD COPY

I

V -"

2 IN 98- March_, 1998 This information notice requires no specific action or written response. If you have any

questions about the information in this notice, please contact the technical contact listed below.

Donald A. Cool, Director, Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Technical Contacts: Steven Baggett, NMSS

301-415-7273 E-mail: slb@nrc.gov

Attachments:

1. Food and Drug Administration Safety Notice

2. List of Recently Issued NMSS Information Notices

3. List of Recently Issued NRC Information Notices

DOCUMENT NAME: H:ATRACI\ISO-IN.WPD

o receive a copy of this document, hIdcate hI the box: 'C' - Copy without attachmentlenclosure 'E' - Copy with attachmentlenclosure 'N' - No copy

OFFICE MSB g 1 MSB 0 Tech Ed I IMOB IMNS

NAME SBagIett LCamper EKraus FCombs DCool

DATE 1- 1//98 Vl7I8 I /98 I /98 I /98 OFFICIAL RECORD COPY