TRIVEX SYSTEM RESECTOR HANDPIECE
Received Aug 22, 2019 · Event occurred Jul 23, 2019
Report 1220948-2019-00112 · MDR key 8923139
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. WHEN THE RUN OR THE WINDOW LOCK BUTTON WAS PRESSED, DRIVE FORK DID NOT ROTATE. UPON DISASSEMBLY, THE ENDBELL'S O-RINGS WERE OBSERVED TO BE DAMAGED FROM INCORRECT ASSEMBLY LIKELY BY SOMEONE AT THE USER FACILITY. RTV UNDER BUTTON APPEARED TO HAVE BEEN REMOVED AND REPLACED. ENDBELL WIRES WERE OBSERVED TO HAVE MOSTLY REMOVED FROM THEIR PINS. WE OBSERVED WATER INGRESS INSIDE THE CORE TUBE AND BOARD WIRES APPEARED TO HAVE BEEN RE-SOLDERED. UPON REMOVAL OF THE DRIVE FORK, WE OBSERVED QUAD RINGS AND BALL BEARING INSTEAD OF SLIP BEARING WHICH IS INCONSISTENT WITH HOW WE BUILT THIS DEVICE. THE DEVICE APPEARED TO HAVE BEEN DISASSEMBLED BY SOMEONE AT THE CUSTOMER LOCATION WITH AN ATTEMPT TO REPAIR. HOWEVER, WE WERE UNABLE TO CONFIRM IF THE PARTS WERE SWAPPED BEFORE OR AFTER THE MALFUNCTION HAD OCCURRED. HENCE, AT THIS TIME, WE COULD NOT CONCLUSIVELY DETERMINE THE CAUSE OF THE FAILURE DUE TO DEVICE TAMPERING BY THE USER FACILITY. BASED ON THE CONDITION THIS DEVICE WAS RECEIVED, THE SURGEON WOULD NOT BE ABLE TO USE THIS DEVICE FOR THE PHLEBECTOMY PROCEDURE. HOWEVER, WE ARE REPORTING THIS INCIDENT AS WE DO NOT HAVE ADEQUATE INFORMATION ON HOW THIS DEVICE WAS HANDLED BEFORE OR AFTER THE EVENT AT THE USER FACILITY. THE ISSUE WAS DETECTED DURING PRE-USE CHECK. DEVICE WAS NOT USED IN THE PATIENT.
Description of Event or Problem
DURING PRE-USE CHECK, THE BLADES OF THE RESECTOR DID NOT SPIN.