MalfunctionJOS
R WOLF ELECTRODE CABLE
Received Aug 12, 2009 · Event occurred Aug 1, 2009
Report 1445427 · MDR key 1445427
Device
Generic name
Cable, Esu, Monopolar, Reuseable
Manufacturer
Richard Wolf Medical Instruments CorporationModel number
8106-033Catalog number
*
Lot number
*
Product problems
- Thermal Decomposition of Device
- Device Issue
Patient
20 YR
- No Information
Narrative
Description of Event or Problem
WHILE USING CAUTERY DURING A LAPAROSCOPIC CASE THE MONOPOLAR CORD "POPPED" AND BURNED IN TWO PIECES. MANUFACTURER RESPONSE (AS PER REPORTER) FOR 10 FT REUSABLE HF ELECTRODE 3.5 MM CONNECTING CABLE, R WOLF ELECTRODE CABLEWILL EXAMINE CORD FOR ISSUE. PRODUCT RETURN #CG00126. SPOKE WITH REP ELEANOR HALL