MalfunctionDWQ
TRIVEX MDU
Received May 24, 2006 · Event occurred Apr 27, 2006
Report 1643264-2006-00028 · MDR key 721636
Device
Generic name
*
Manufacturer
Smith & Nephew, Inc./endoscopy DivisionModel number
7210387Catalog number
7210387
Lot number
S
Product problems
- System fails to activate
Patient
UNKNOWN
- Surgical procedure, repeated
- Surgery, prolonged
Narrative
Description of Event or Problem
THE RESECTOR FAILED TO ACTIVATE.THE SURGEON DISASSEMBLED THE CABLE TO SEE IF MOISTURE WAS PRESENT AND THERE WAS NONE. THE PT REQUIRED A SECOND SURGERY TO COMPLETE THE PROCEDURE AS NO BACK-UP MDU WAS AVAILABLE. A ONE-HOUR DELAY WAS EXPERIENCED IN THIS VEIN LIGATION PROCEDURE.