TRIVEX SYSTEM RESECTOR HANDPIECE
Received May 9, 2019 · Event occurred Apr 10, 2019
Report 1220948-2019-00055 · MDR key 8597023
Device
Generic name
Varicose Vein Albation System
Manufacturer
Lemaitre Vascular, Inc.Catalog number
7210387F
Lot number
YB02177
Product problems
- No Device Output
- No Device Output
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 COMPLAINT DEVICE FOR EVALUATION AND WE HAVE CONFIRMED THE REPORTED INCIDENT. THE HANDPIECE CABLE AND POWER CABLE WERE INSPECTED AND WERE FOUND TO BE ACCEPTABLE. HANDPIECE WAS THEN CONNECTED INTO THE CONTROL UNIT. WHEN EITHER THE RUN OR THE WINDOW LOCK BUTTON WAS PRESSED, THE INDICATOR LIGHT ON THE CONTROL UNIT FLASHED ORANGE INDICATING AN ISSUE WITH THE HANDPIECE AND THE DRIVE SHAFT WOULD NOT TURN . UPON DISASSEMBLY, WE DID NOT OBSERVE ANY COMPONENT FAILURE. HOWEVER, THE SEAL HOUSING WAS OBSERVED TO HAVE HEAT DISCOLORATION. THE LIKELY ROOT CAUSE OF THIS ISSUE IS A SEIZED BALL BEARING. OVER TIME, PARTICULATES AND WATER COULD ENTER INTO THE BALL BEARING ASSEMBLY SINCE IT IS NOT A HERMATICALLY SEALED COMPONENT. WE HAVE ALREADY IMPLEMENTED A CORRECTIVE AND PREVENTIVE ACTION (CAPA) TO RESOLVE THIS ISSUE BY REPLACING THE BALL BEARINGS WITH SLIP BEARINGS WHICH BETTER PREVENT THE BEARINGS FROM CORROSION AND FROM SEIZING. THIS DEVICE WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF THESE CHANGES. THERE WAS NO HARM TO THE PATIENT AS THE RESULT OF THIS INCIDENT. THE PROCEDURE WAS COMPLETED USING A DIFFERENT HANDPIECE.
Description of Event or Problem
THE RESECTOR FAILED TO ROTATE DURING PRE-USE CHECK.