EXCEL CONMED PNEUMOPERITONEUM INSUFF NEEDLE

Description of Event or Problem

IT WAS REPORTED THAT, "DURING A LAVH, THE SURGEON PERFORATED THE BOWEL AND THE MESENTERY MEMBRANE. BOTH WERE REPAIRED IMMEDIATELY DURING THE SURGICAL PROCEDURE. THE PROCEDURE WAS NOT ALTERED. THE STATUS OF THE PATIENT WAS REPORTED AS, "OK".

Additional Manufacturer Narrative

THE ACTUAL DEVICE WAS DISCARDED AT THE HOSPITAL. A NEW UNUSED DEVICE OF THE SAME LOT CODE WAS RETURNED FOR EVALUATION. THE DEVICE PRODUCTION RECORDS WERE REVIEWED. THESE WERE FOUND TO BE CORRECT. THE DEVICE WAS VISUALLY EXAMINED AND FOUND TO BE ASSEMBLED CORRECTLY. IT WORKED AS STATED IN THE PRODUCT INSERT. THE REPORT INDICATED THAT THE PERFORATIONS OCCURED BECAUSE THE SURGEON "DID NOT HEAR THE CLICK." THE PRODUCT INSERT IS INCLUDED AS PAGE 3 OF 3. THERE IS NO INDICATION THAT THE DEVICE IS SOLD AS AN AUDIBLE DEVICE. THE INSERT REFERENCES THE SURGEON "FEELING A CLICK" WHEN INSERTING THE NEEDLE. THE RETURNED DEVICE WORKED AS DESIGNED TO. WE FEEL THE PERFORATION MOST LIKELY OCCURED DUE TO AN ERROR IN THE SURGEON'S TECHNIQUE FOR JUDGING THE NEEDLE PLACEMENT AND THE INSERTION DEPTH. WE CONSIDER THIS COMPLAINT CLOSED AND THE INVESTIGATION COMPLETED.