TRIVEX SYSTEM RESECTOR HANDPIECE
Received Jan 2, 2019 · Event occurred Dec 3, 2018
Report 1220948-2019-00001 · MDR key 8210315
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 AND WE HAVE CONFIRMED THE REPORTED INCIDENT. THE STATUS LIGHT ON THE CONTROL UNIT FLASHED ORANGE WHEN THE HANDPIECE WAS CONNECTED INTO THE CONTROL UNIT INDICATING AN ISSUE WITH THE HANDPIECE. THE DRIVE SHAFT DID NOT ROTATE AT ALL WHEN EITHER THE WINDOW LOCK OR THE RUN BUTTON WAS PRESSED. FURTHER INSPECTION FOUND A SMALL AMOUNT OF MOISTURE IN THE CORE TUBE. IT IS LIKELY THE WATER INGRESS INSIDE THE CORE TUBE DAMAGED THE ELECTRICAL COMPONENTS INSIDE THE HANDPIECE AFFECTING THE MOTOR FUNCTIONALITY. WE CURRENTLY HAVE A CORRECTIVE AND PREVENTIVE ACTION (CAPA) OPEN TO ADDRESS THIS ISSUE. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT. SURGEON PERFORMED STAB PHLEBECTOMY TO COMPLETE THE SURGERY.
Description of Event or Problem
DURING THE TRANSILLUMINATED POWERED PHLEBECTOMY PROCEDURE (TIPP), THE HANDPIECE STOPPED WORKING.