PNEUMOPERITONEUM NEEDLE

Description of Event or Problem

DURING A LAPAROSCOPIC PROCEDURE, THE STYLET DID NOT ALLEGEDLY RETURN TO ITS CORRECT POSITION TO COVER THE NEEDLE FROM EXPOSURE. THE CUSTOMER DIDN'T RETURN THE PRODUCT FOR AN EVAL. THE INVESTIGATION IS STILL IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED AT A LATER DATE.

Additional Manufacturer Narrative

ALL SUSPECTED UNITS HAVE BEEN RECALLED. THE REPORTED PROBLEM HAS BEEN CORRECTED BY MODIFICATIONS MADE TO THE MFG PROCESS.