ELECTRODE EXTENSION - 11 INCH
Received Apr 30, 2009 · Event occurred Apr 3, 2009
Report 1717344-2009-00175 · MDR key 1429477
Device
Generic name
Electrosurgical Accessory
Manufacturer
Covidien Lp (valleylab)Catalog number
E1504
Lot number
UNKNOWN
Product problems
- Detachment Of Device Component
- Component Falling
Patient
34 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT WHEN USING THE EXTENDER IN A LAPAROSCOPIC PROCEDURE USING A 10MM TROCAR, THE ELECTRODE TIP CAME OFF THE EXTENDER AS IT WAS WITHDRAWN FROM THE TROCAR AND FELL INTO THE PT CAVITY. THERE WAS NO PT INJURY AND THE TIP WAS REMOVED FROM THE PT'S ABDOMEN WITH A LAPAROSCOPIC GRASPER. THE TIP HAD BEEN INTENTIONALLY BENT WITH A SLIGHT CURVE DURING BLADDER DISSECTION WHICH THEY NORMALLY DO FOR THIS PROCEDURE.
Additional Manufacturer Narrative
THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.