TRIVEX SYSTEM RESECTOR HANDPIECE
Received Oct 30, 2018 · Event occurred Sep 30, 2018
Report 1220948-2018-00091 · MDR key 8021529
Device
Product problems
- Failure to Conduct
- Failure to Conduct
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 DEVICE FOR EVALUATION. WE OBSERVED THAT THE RUN BUTTON AND THE HERMETIC HEADER ASSEMBLY HAD BEEN REMOVED FROM THE BEZEL AND HOUSING. SOME OF THE WIRES THAT CONNECT THE MOTOR AND OTHER COMPONENTS TO THE END BELL CONNECTOR PINS HAD BEEN DISCONNECTED AND SOME OF THE WIRES WERE MISSING THE HEAT SHRINK. BASED ON THE CONDITION THE DEVICE WAS RECEIVED, IT IS LIKELY THE DEVICE WAS MANIPULATED WITH SOME ATTEMPT TO REPAIR. THE RESECTOR WOULD NOT ROTATE AND THE SURGEON WOULD NOT BE ABLE TO USE THIS DEVICE FOR THE PHLEBECTOMY PROCEDURE. BASED ON THE LIMITED AVAILABLE INFORMATION WE HAVE AT THIS TIME, WE ARE REPORTING THIS INCIDENT AS WE DO NOT HAVE ADEQUATE INFORMATION ABOUT HOW THE DEVICE WAS HANDLED AFTER THE EVENT AT THE USER FACILITY. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT SINCE THE ISSUE WAS DETECTED DURING PRE-USE CHECK. THE PROCEDURE WAS COMPLETED USING ANOTHER HANDPIECE THAT THEY HAVE IN STOCK .
Description of Event or Problem
DURING PRE-USE CHECK, THE BLADES OF THE RESECTOR DID NOT SPIN.