MalfunctionDWQ
TRIVEX SYSTEM VARICOSE VEIN TREATMENT
Received Oct 1, 2010 · Event occurred Aug 13, 2010
Report 1860425 · MDR key 1860425
Device
Generic name
Trivex Vein Treament System Hand Piece
Manufacturer
Smith & Nephew, Inc.-endoscopyModel number
NACatalog number
7210387
Lot number
YQ01435
Product problems
- Break
Patient
54 YR
- No Information
Narrative
Description of Event or Problem
SURGERY WAS STOPPED 37 MINUTES AFTER INCISION DUE TO A BROKEN PIECE OF EQUIPMENT. THE PIECE IS THE TRIVEX HAND PIECE. THE PLASTIC ACTIVATION SWITCH FELL APART WHEN THE SURGEONS STARTED TO USE IT. THE FAULTY TRIVEX PIECE WAS GIVEN TO BIOMED.