TRIVEX SYSTEM RESECTOR HANDPIECE
Received Oct 24, 2019 · Event occurred Sep 24, 2019
Report 1220948-2019-00145 · MDR key 9235123
Device
Product problems
- Power Problem
- Power Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
WE HAVE RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. HOWEVER, WE WERE UNABLE TO CONFIRM THE REPORTED INCIDENT. WE HAVE INSPECTED THE HOUSING AND POWERCABLE OF THE HANDPIECE AND FOUND THEM TO BE ACCEPTABLE. DEVICE OPERATED PROPERLY ON ALL SETTINGS AND FUNCTIONS. HOWEVER, UPON DISASSEMBLY, WE OBSERVED MOISTURE INSIDE THE CORE TUBE THAT HAD PENETRATED INTO THE ADHESIVE OF THE PC BOARD. WE ALSO OBSERVED CORROSION ON THE HEAT SINK AND MOTOR. WE HAVE IMPLEMENTED A CORRECTIVE AND PREVENTIVE ACTION (CAPA) TO ADDRESS THIS ISSUE. BASED ON OUR INVESTIGATION, WE HAVE UPDATED THE DESIGN OF THE HANDPIECE WATER SEALS, WHICH WILL BETTER PREVENT WATER AND STEAM FROM ENTERING INTO THE INNER COMPONENTS OF THE HANDPIECE. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT. SURGEON REPLACED THE HANDPIECE TO COMPLETE THE REMAINING PROCEDURE.
Description of Event or Problem
DURING PROCEDURE, THE RESECTOR OF THE HANDPIECE STOPPED SPINNING. HOWEVER, AFTER FEW ATTEMPTS, SURGEON WAS ABLE TO GET THE DEVICE TO WORK PROPERLY.