inforMED
MalfunctionFHO

PNEUMOPERITONEUM NEEDLE

Received Jun 28, 1997

Report 2939738-1997-00021 · MDR key 102476

Device

Generic name

Pheumoperitoneum Needle

Model number

OMS-N120

Catalog number

OMS-N120

Lot number

2003971

Product problems

  • Malfunction

Patient

UNKNOWN

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

DURING A LAPAROSCOPIC PROCEDURE, THE SPRING STYLET ON THE PNEUMONEEDLE FAILED TO RETURN TO ITS PROPER POSITION, THEREFORE EXPOSING THE NEEDLE END. THE INVESTIGATION IS STILL IN PROGRESS.