GAMMAMED

Additional Manufacturer Narrative

ADD'L INFO REGARDING THOSE INDIVIDUALS THAT HAVE BEEN EXPOSED TO UNINTENDED RADIATION DURING THE INCIDENT AND SUBSEQUENT RECOVERY OF THE SOURCE, IS PENDING AT THIS TIME; DOSE INFO IS EXPECTED TO BE RECEIVED BY THE (B)(6), 2011. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE AS THIS POSSIBLE MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE UNINTENDED RADIATION EXPOSURE DURING THE RECOVERY OF THE STUCK SOURCE AND RESULT SERIOUS INJURY. ADD'L FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

THE CUSTOMER INFORMED THE LOCAL FIELD SERVICE ENGINEER (FSE) THAT THE SOURCE WAS OUT OF THE SHIELDING OF THE (B)(4), AND COULD NOT BE RETRACTED BY THE EMERGENCY DRIVE NOR BY THE EMERGENCY HAND CRANK. THE CUSTOMER LOCKED AND SECURED THE TREATMENT ROOM, WAITING FOR THE FSE TO COME. THE SOURCE WIRE GOT STUCK IN A TYPE "2" CLAMPING ADAPTER. TO REMOVE THE SOURCE WIRE OUT OF THE MACHINE THEY DECIDED TO CUT THE WIRE AND DROP IT INTO THE EMERGENCY CONTAINER.