MalfunctionFHO
PNEUMOPERITONEUM NEEDLE
Received Aug 1, 1997
Report 2939738-1997-00029 · MDR key 110753
Device
Generic name
Pneumoperitoneum Needle
Manufacturer
Origin Medsystems, Inc.Model number
OMS-N120Catalog number
OMS-N120
Lot number
0704971
Product problems
- Retraction Problem
Patient
UNKNOWN
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING A LAPAROSCOPIC PROCEDURE, THE NEEDLE STYLET ALLEGEDLY FAILED TO RETURN TO ITS PROPER PLACE TO COVER THE NEEDLE.
Remedial action
- Modification/Adjustment
- Recall