MalfunctionFHO
PNEUMOPERITONEUM NEEDLE
Received Mar 14, 1997
Report 2939738-1997-00014 · MDR key 76953
Device
Generic name
Pneunoperitoneum Needle
Manufacturer
Origin MedysystemsModel number
OMS-N120Catalog number
OMS-N120
Lot number
0808961
Patient
UNKNOWN
Narrative
Description of Event or Problem
DURING A PROCEDURE, STYLET ON THE UNIT ALLEGEDLY FAILED TO RETURN TO ITS PROPER POSITION TO COVER THE NEEDLE. THE DEVICE HISTORY RECORD REVIEW INDICATED THERE WAS NO LOT SPECIFIC PROBLEM.
Remedial action
- Other