MalfunctionFHO
PNEUMONEEDLE, 120MM
Received Jul 20, 1999
Report 2939738-1999-00022 · MDR key 233397
Device
Generic name
Pneumo Peritoneum Needle
Manufacturer
Origin Medsystems, Inc.Model number
OMS-N120Catalog number
00556
Lot number
0601981
Product problems
- Break
- Needle, separation
- Difficult to Remove
Patient
NO INFO
- No Consequences Or Impact To Patient
- Foreign body, removal of
Narrative
Description of Event or Problem
DURING THE WITHDRAWL OF THE NEEDLE, THE NEEDLE SEPARATED FROM THE BASE PLATE AND REMAINED INSIDE THE PATIENT. THE SURGEON FOUND IT VERY DIFFICULT TO RECOVER THE NEEDLE. THE BROKEN PIECE WAS RETRIEVED WITHOUT ANY COMPLICATIONS TO THE PATIENT.
Remedial action
- Other