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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 54136 | 26 June 2019 04:00:00 | Agreement State | Agreement State Report - Brachytherapy Underdose Due to Dislodging of Device | The following was received via e-mail: A patient was planned for a HDR (high dose rate) brachytherapy vaginal cuff treatment, fraction 1 of 2, at 5 Gy per fraction. A vaginal cylinder was placed in the vaginal canal and the positioning was verified with a cone beam CT scan. The cylinder was then connected to the afterloader containing the Ir-192 source (3.449 Ci; GammaMed 232 S/N: 24-01-7273-001-020819-12601-99) and treatment commenced. Upon completion of the treatment, it was observed that the vaginal cylinder was dislodged from the initial position. The cylinder was found between the legs, outside the vaginal canal, in contact with the perineal region. The patient indicated that she had coughed at some point during the treatment, which may have contributed to the dislodgement of the cylinder. The estimated skin dose is 5 Gy (500 rad). No erythema was observed at the time of discovery. The patient and referring physician have been notified. Ohio Item Number: OH190009 A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.
The following retraction information was obtained from the state of Ohio via email: An inspection was conducted on July 15, 2019 to investigate the event. It was determined that the applicator was properly secured for the prescribed treatment, but was dislodged by the patient. Since the cause was patient intervention, this is not a medical event. Notified R3DO (Edwards) and NMSS Events Notification (email). | ||
| ENS 53613 | 19 September 2018 04:00:00 | Agreement State | Agreement State Report - Package Arrived with Surface Contamination | The following information was obtained from the Ohio Department of Health via email: At approximately 0730 EDT on 9/19/18, a package containing Tc-99m was received by the Cleveland Clinic Foundation from Cardinal Health in Oakwood, OH that exceeded the DOT surface contamination limits. The contact dose rates were incompliance. An initial wipe for removable contamination showed 1258 cpm over 300 cm2 of the package surface. Wipes of the handle (10759 cpm), the zipper (11290 cpm) and the top address label cover (24342 cpm) identified additional removable contamination on the package. Conversion to dpm with appropriate area correction resulted in 2946 dpm/cm2. No other contamination was found in the lab or package receipt area. A follow-up inspection at Cardinal Health in Oakwood will be conducted to determine the cause of the event. Ohio NMED Report No.: OH180008 |