MalfunctionFHO
PNEUMOPERITONEUM NEEDLE
Received Jul 11, 1997
Report 2939738-1997-00026 · MDR key 105645
Device
Generic name
Pneumoperitoneum Needle
Manufacturer
Origin Medsystems, Inc.Model number
OMS-N120Catalog number
OMS-N120
Lot number
0503971
Patient
UNKNOWN
Narrative
Description of Event or Problem
DURING A LAPAROSCOPIC HERNIA REPAIR, THE NEEDLE STYLET ALLEGEDLY DID NOT RETURN TO ITS PROPER PLACE TO COVER THE NEEDLE. ROOT CAUSE HAS NOT BEEN DETERMINED YET, INVESTIGATION IS STILL IN PROGRESS.
Remedial action
- Recall