KELLY FORCEPS DEL CVD 140MM

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A HEMOSTAT VIA INFORMATION RECEIVED FROM MEDSUN (B)(4). ACCORDING TO THE COMPLAINT DESCRIPTION, DURING THE CREATION OF A LEFT BRACHIAL ARTERY TO LEFT AXILLARY VEIN ARTERIOVENOUS GRAFT PERFORMED IN (B)(6) 2025, THE TIP OF THE CRILE HEMOSTATIC FORCEPS BROKE WHILE THE SURGICAL TECHNICIAN WAS UNCLAMPING OFF THE SURGICAL SITE. AN X-RAY WAS PERFORMED AND THE RESULTS CONFIRMED THAT THERE WERE NO FRAGMENTS IN SITU. THE ADVERSE EVENT IS FILED UNDER AESCULAP REFERENCE NO. (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

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.