SILICONE RING WITH NEEDLE

Description of Event or Problem

IT WAS REPORTED TO AESCULAP INC. THAT A SILICONE RING WITH NEEDLE (PART# PL595SU) WAS USED DURING A PROCEDURE ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT, WHILE RETRACTING THE GALLBLADDER, THE GRAY SILICONE RING SNAPPED IN HALF AND DETACHED ON THE PATIENT'S GALLBLADDER WITH THE CLIP ATTACHED. THE RING WAS RETRIEVED WITH A GRASPER AND NO IMAGING WAS REQUIRED. THE SILICONE RING WAS DISCARDED, AND THEREFORE, WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).

Additional Manufacturer Narrative

INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

UPDATED INFORMATION: F9 APPROXIMATE AGE OF DEVICE. MANUFACTURING SITE EVALUATION: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION OF THE UNIT WAS PERFORMED AND NO PARTS WERE RETURNED FOR FAILURE ANALYSIS. THEREFORE, THE INVESTIGATION WAS NOT ABLE TO CONFIRM A DEVICE ISSUE THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED FOR THE AVAILABLE LOT NUMBER; THE DEVICE WAS FOUND TO BE WITHIN SPECIFICATION AT THE TIME OF PRODUCTION. ALL DEVICE HISTORY RECORDS (DHR) ARE REVIEWED AND RELEASED ACCORDING TO DOCUMENTED PROCEDURES AND A DEVICE IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.