MalfunctionFHO
PNEUMOPERITONEUM NEEDLE
Received Nov 25, 1997
Report 2939738-1997-00037 · MDR key 135431
Device
Generic name
Pneumoperitoneum Needle
Manufacturer
Origin Medsystems, Inc./guidant CorporationModel number
OMS-N150Catalog number
OMS-N150
Lot number
2804971
Patient
UNKNOWN
Narrative
Description of Event or Problem
A CUSTOMER ALLEGEDLY REPORTED THAT THE PNEUMOPERITONEUM NEEDLE'S SPRING WAS NOT WORKING. ORIGIN PERFORMED A VOLUNTARY RECALL OF ALL SUSPECTED UNITS. THE DISTRIBUTOR REPORTED THAT ALL THE NEEDLES HAD BEEN RETURNED TO ORIGIN, AND THAT UNITS NOT RETURNED WERE ASSUMED TO HAVE BEEN CONSUMED BY THE FACILITY(IES). WEEKS LATER, CO RECEIVED THIS REPORT WITH THE SAME ALLEGED COMPLAINT REGARDING THE NEEDLES.
Additional Manufacturer Narrative
RECALL NO. Z-874/875-7.
Remedial action
- Modification/Adjustment
- Recall