MalfunctionFFZ
*
Received Oct 10, 2003 · Event occurred Dec 1, 2002
Report 489102 · MDR key 489102
Device
Generic name
Electrosurgical Unit Active Electrode Unipolar Cord
Manufacturer
Karl Storz Endoscopy-america, Inc.Model number
*Catalog number
26006M
Lot number
*
Product problems
- Smoking
- Use of Device Problem
- Sparking
Patient
59 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
AN ESU CAUTERY CORD CAUGHT FIRE DURING A PROCEDURE. THE FIRE WAS DESCRIBED AS SPARKS AND SMOKE ONLY, NO ACTUAL FIRE. THE CORD AND ESU WERE REMOVED FROM THE ROOM. NO INJURY WAS CAUSED TO THE PATIENT. THE REPORTING NURSE SAID THAT THE USERS [SURGICAL TECHS] HAD BENT THE CORD AND TAPED IT TO THE SCISSORS TO KEEP THE CONNECTOR FROM FALLING OUT. DEVICE USAGE PROBLEM: DEVICE FAILED.