YASARGIL APPL.FCPS STD.TI.90/220MM

Additional Manufacturer Narrative

INVESTIGATION: THE INVESTIGATION WAS CARRIED OUT VISUALLY. AT THE WORKING END, AT THE PRISM, SIGNIFICANT DEFORMATIONS CAN BE FOUND, THUS A FUNCTIONAL TEST CAN NOT BE CARRIED OUT. THE JAW IS NOT TRUE TO GAUGE AND THE OPENING RANGE OF THE HANDLES IS TOO TIGHT. THE CATCH IS MISSING COMPLETELY. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO AN INSUFFICIENT MAINTENANCE OF THE DEVICE. RATIONAL: THE FORCEPS SHOWS SIGNIFICANT SIGNS OF WEAR AND TEAR, MOST LIKELY CAUSED BY IMPROPER USAGE. IN PARTICULAR THE JAW IS VERY DAMAGED AND NOT LONGER ACCORDING TO THE SPECIFICATIONS. CORRECTIVE ACTION: ACCORDING TO SOP SA-DE13-M-4-2-01-010. A CAPA IS NOT NECESSARY.

Additional Manufacturer Narrative

AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING. CORRECTION: H1: DEATH.

Description of Event or Problem

COUNTRY OF COMPLAINT: BRAZIL. DURING A SURGICAL PROCEDURE THE TWEEZERS DID NOT HOLD THE CLIP ACCURATELY AND AFTER CLIPPING, THE CLIP DID NOT RELEASE PROPERLY. DUE TO THIS THE PATIENT'S ANEURYSM RUPTURED. THE PATIENT WAS TAKEN TO INTENSIVE CARE IN SERIOUS CONDITION AND THE PATIENT DIED.