CONMED UNIVERSAL PLUS STEALTH ES ELECTRODE
Received Nov 4, 2009 · Event occurred Oct 6, 2009
Report 1320894-2009-00115 · MDR key 1552442
Device
Generic name
Laparoscopic Electrode
Manufacturer
Conmed CorporationModel number
NACatalog number
60-5274-032
Lot number
0906251
Product problems
- Detachment Of Device Component
Patient
66 YR
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
IT WAS REPORTED THAT "PROCEDURE: LAPAROSCOPIC CHOLECYSTECTOMY. INCIDENT OCCURRED INTRA-OPERATIVELY. THE SURGEON WAS DISSECTING THE GALLBLADDER FROM THE LIVER BED, WHEN SHE NOTICED, SHE WAS NOT GETTING GOOD RESULTS FROM THE DISSECTION. SHE ASKED HER SCRUB TO CLEAN THE TIP. IT WAS NO LONGER ATTACHED TO PROBE. IT WAS FOUND IN GB BED AFTER X-RAYS WERE TAKEN. NO IMMEDIATE ADVERSE REACTION".
Additional Manufacturer Narrative
THE DEVICE IS CURRENTLY BEING HELD AT THE USER FACILITY. CONMED IS WORKING WITH FACILITY TO MAKE ARRANGEMENTS FOR THE DEVICE TO BE RETURNED FOR EVAL. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.