PNEUMOPERITONEUM NEEDLE
Received Jan 15, 1998
Report 2939738-1997-00042 · MDR key 145198
Device
Generic name
Pneumoperitoneum Needle
Manufacturer
Origin Medsystems, Inc.Model number
OMS-N120Catalog number
0MS-N120
Lot number
UNK
Product problems
- Retraction Problem
- Device Issue
Patient
UNKNOWN
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Additional Manufacturer Narrative
COMPLAINT CONFIRMED. THE NEEDLE STYLET DOES NOT RETRACT BACK WHEN THE NEEDLE IS PUSHED FORWARD. CAUSE OF FAILURE: THE CAUSE OF FAILURE WAS DUE TO MISALIGNMENT BETWEEN THE HOUSING ASSEMBLY AND THE STYLET. THE MISALIGNMENT INCREASES THE FRICTION BETWEEN THE NEEDLE AND THE STYLET CAUSING THE STYLET NOT TO RETRACT. IS CORRECTIVE OR PREVENTIVE ACTION REQUIRED? YES. HAS ACTION ALREADY BEEN TAKEN OR ISSUED FOR A SIMILAR EVENT? YES.
Description of Event or Problem
DURING A LAPAROSCOPIC PROCEDURE, THE REPORTER INDICATED THAT THE SPRING ON THE NEEDLE ALLEGEDLY IS NOT WORKING.
Remedial action
- Recall