ML20216F682
| ML20216F682 | |
| Person / Time | |
|---|---|
| Issue date: | 03/19/1998 |
| From: | Larkins P NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | NRC |
| Shared Package | |
| ML20216F665 | List: |
| References | |
| NUDOCS 9804170191 | |
| Download: ML20216F682 (1) | |
Text
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Froms.
Patricia Larkins
'To dbh Date:
3/19/98 2:28pm
)
Subject:
MICHAEL REESE MEDICAL EVENT
<WP Attachment Enclosed > ATTACHED IS AN EMAIL THAT I RECEIVED FROM IL PRIOR TO THEIR DISCUSSION WITH MICHAEL REESE RE MY SPECIFIC. QUESTIONS. Also attached
.is a note to file re my telcon with.'IL after.their discussion with the licensee.
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l 9804170191 990415 PDR ORG NOMA PDR
/
From:
Joe Klinger <klinger@idns. state.il.us>
To:
WND1.WNP9(PML)
Date:
3/3/98 4:39pm
Subject:
12/17/97 event at Michael Reese Hosp.
Pat:
Your email re same subject has been forwarded to me. Pts. note that I am now Chief of the Division of Radioactive Materials. Your questions are interesting and we raised some of the same concerns but felt the concerns came under FDA jurisdiction and medical practice so did not pursue further. I contacted Michael Reese Hospital, and they will provide answers to the questions hopefully tomorrow, Wed.,3/4. As soon as I obtain the info I will call you or email you. l(further discussion with the applicant is necessary we can decide the best means of obtaining with the least disruption of all parties. I did leam from the licensee that the change in the needle tip and a different ultrasound unit resulted in improved visualization and essentially no needles were misapplied in a later prostate treatment procedure. Joe Klinger I
I 1
i
t.,
March 5,1998-NOTE TO FILE
SUBJECT:
3/5/98 TELCON WITH JOE KLINGER, ILL, RE FOLLOWUP INFORMATION ON 12/17/97, MICHAEL REESE HOSPITAL EVENT The IL staff provided a response to the following question.
1.
The identity of the manufacturer:
Ans.
Manan Medical Products No. Brook, IL which has been bought out by Medical Device Tech (Med Tech)
Gainesville, FL Tel. 1-800-338-0440 2.
The specific needle tip modification that occurred at the request of the customer (licensee)
Ans.
A salesman lead the licensee to believe needle tip changes would occur. Instead the manufacturer increased scrutinization of the needle tips for acceptability. An improvement in the Q/A took place.
Licensee resolution:
Licensee was using (Acuson ultrasonic unit) an all purpose type ultrasound unit. They switched to a Seamans Prima unit which provides greater visual clarity. Not a single needle wound up in -
the bladder,
.Filen: MIRES 2.ll i
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