TRIVEX SYSTEM CONTROL UNIT WITH BUILT IN PUMP

Additional Manufacturer Narrative

WE HAVE NOT RECEIVED THE DEVICE FOR EVALUATION SINCE THE DEVICE IS STILL IN THE POSSESSION OF THE HOSPITAL. HENCE, WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE DEFECT. ON 8/8/2018, THE SALES REP. VISITED THE HOSPITAL AND TESTED THE REPORTED COMPLAINT DEVICE. SHE CONFIRMED THAT THE BLADES OF THE HANDPIECE DID NOT ROTATE AT ALL WHEN THE HANDPIECE WAS CONNECTED IN THE CONTROL UNIT. THE ISSUE WAS DETECTABLE WHEN PRESSING EITHER THE RUN OR THE WINDOW LOCK BUTTON. OTHER HANDPIECES OPERATED NORMALLY WHEN CONNECTED TO THE SAME CONTROL UNIT. THERE WAS NO IMPACT ON THE PATIENT'S HEALTH AS THE RESULT OF THIS INCIDENT. THE ISSUE WAS DETECTED DURING THE PRE-USE CHECK AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT HANDPIECE IN STOCK. THE DEVICE WAS NON-FUNCTIONAL AND THEREFORE THE MALFUNCTION WAS DETECTED PRIOR TO THE CASE. THERE HAS BEEN NO SERIOUS INJURY (SECTION 2.13) NOR WOULD THE MALFUNCTION RESULT IN A DEATH OR SERIOUS INJURY IF IT WAS TO REOCCUR I.E THE DEVICE NEVER FUNCTIONED AT ANY POINT OF THE CASE AND THEREFORE THE PATIENT WAS NEVER EXPOSED OR POTENTIALLY EXPOSED, TO THE DEVICE. HOWEVER, WE HAVE DECIDED TO REPORT THE INCIDENT SINCE OUR EVALUATION WAS BASED ON THE REPORTED DEFECT FROM OUR SALES REP. AND THE USER AT THE HOSPITAL RATHER THAN OUR HANDS-ON EVALUATION WITH THIS DEFECTIVE DEVICE ITSELF.

Description of Event or Problem

DURING PRE-USE CHECK, THE BLADES OF THE RESECTOR DID NOT SPIN.