MalfunctionGDO
LIGACLIP ENDOSCOPIC SINGLE CLIP APPLIER
Received Dec 17, 1998 · Event occurred Oct 17, 1998
Report 1527736-1998-04210 · MDR key 202550
Device
Generic name
Clip Appliers - Endoscopic/reusable
Manufacturer
Post Surgical MfgModel number
NACatalog number
EL314
Lot number
NA
Product problems
- Misfire
Patient
UNKNOWN
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A EL314 WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED BY THE AFFILIATE THAT THE INSTRUMENT DROPS THE CLIPS INSIDE THE PT'S BODY.
Remedial action
- Other