TRIVEX SYSTEM RESECTOR HANDPIECE
Received Mar 8, 2019 · Event occurred Feb 9, 2019
Report 1220948-2019-00022 · MDR key 8405620
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. THE HANDPIECE WAS RETURNED TO US WITH THE DRIVE SHAFT DISASSEMBLED FROM THE MOTOR UNIT. THE END BELL THAT SECURES THE SEAL HOUSING TO THE CORE TUBE WAS ALSO MISSING. THE PCB WIRES TO THE END BELL WERE CUT AND THE DRIVE SHAFT PIN AND RETAINER CUP WERE ALSO MISSING ALONG WITH SEAL HOUSINGS' INTERNAL COMPONENTS AND BEARINGS. BASED ON THE CONDITION THIS DEVICE WAS RECEIVED, 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 THIS DEVICE WAS HANDLED AFTER THE EVENT AT THE USER FACILITY. THE ISSUE WAS DETECTED DURING PRE-USE CHECK AND THE DEVICE WAS NOT USED IN THE PATIENT.
Description of Event or Problem
DURING PRE-USE CHECK, THE BLADES OF THE RESECTOR DID NOT SPIN.