MalfunctionGDO
LIGACLIP ENDOSCOPIC SINGLE CLIP APPLIER
Received Feb 7, 2000
Report 1527736-2000-00371 · MDR key 261543
Device
Generic name
Clip Appliers - Endoscopic
Manufacturer
Post Surgical MfgModel number
NACatalog number
EL214
Lot number
UNK
Product problems
- Loose
- Failure to Form Staple
Patient
UNKNOWN
- Failure to Anastomose
- Foreign body, removal of
Narrative
Description of Event or Problem
IT WAS REPORTED THAT (1) DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE EL214 JAWS BECAME LOOSE AND DO NOT HOLD THE CLIP SECURELY. 1/11/2000 MESSAGE FROM AFFILIATE. THE CLIPS FELL INTO THE PT AND WERE RETRIEVED. NO FURTHER COMPLICATIONS TO THE PT.
Remedial action
- Other