MalfunctionFHO
PNEUMOPERITONEUM NEEDLE
Received Jul 9, 1997
Report 2939738-1997-00024 · MDR key 105640
Device
Generic name
Pneumoperitoneum Needle
Manufacturer
Origin Medsystems, Inc.Model number
OMS-N120Catalog number
OMS-N120
Lot number
0804971
Patient
UNKNOWN
Narrative
Description of Event or Problem
DURING A GYNECOLOGICAL PROCEDURE, THE NEEDLE'S STYLET ALLEGEDLY DID NOT RETURN TO ITS PROPER POSITION TO COVER THE NEEDLE. THE INVESTIGATION IS STILL PROGRESS.
Additional Manufacturer Narrative
ALL SUSPECTED UNITS HAVE BEEN RECALLED. THE REPORTED PROBLEM HAS BEEN CORRECTED BY MODIFICATIONS MADE TO THE MFG PROCESS.
Remedial action
- Modification/Adjustment
- Recall