TRIVEX SYSTEM RESECTOR HANDPIECE
Received Oct 30, 2018 · Event occurred Sep 30, 2018
Report 1220948-2018-00092 · MDR key 8021530
Device
Product problems
- Failure to Conduct
- Failure to Conduct
Patient
Not reported
- No Information
- No Information
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. ALL OF THE WIRES THAT CONNECT THE MOTOR AND OTHER COMPONENTS TO THE ENDBELL CONNECTOR PINS HAD BEEN DISCONNECTED. 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 BY STAB PHLEBECTOMY PROCEDURE SINCE THEY DO NOT HAVE ANY OTHER HANDPIECES IN STOCK.
Description of Event or Problem
DURING PRE-USE CHECK, THE BLADES OF THE RESECTOR DID NOT SPIN.