BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KELLY FORCEPS DEL CVD 140MM

    MDR report key: 8621593 · Received May 17, 2019

    Report

    Report Number
    9610612-2019-00345
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    February 22, 2019
    Report Date
    May 17, 2019
    Manufacturer
    AESCULAP AG
    Product Code
    HRQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER, REGISTRATION NO. 9610612). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: THE INSTRUMENTS ARRIVED IN A DECONTAMINATED CONDITION AND THEY ARE AVAILABLE FOR INVESTIGATION. THE INSTRUMENTS HAD VISIBLE DAMAGE AND THE BROKEN OFF PARTS. INVESTIGATION: PERFORMED VISUALLY AND MICROSCOPICALLY. HERE WE MADE AN OPTICAL INSPECTION OF THE FRACTURE SURFACE, AND FOUND DISCOLORATION AND CRACKS. WE ALSO DISCOVERED AN INTERCRYSTALLINE FRACTURE. A VISUAL INSPECTION OF THE BROKEN OFF PARTS SHOWED VISIBLY DAMAGED TOOTH TIPS. ADDITIONALLY, INSPECTION OF THE FRACTURE SURFACE SHOWED DISCOLORATION, CRACKS, AND UNKNOWN RESIDUES; AND AN INTERCRYSTALLING FRACTURE. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE LOT NUMBER AND FOUND TO BE ACCORDING TO THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. ONE SIMILAR INCIDENT HAS BEEN FILED WITH A PRODUCT FROM THE BATCH. CONCLUSION AND ROOT CAUSE: THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY MANUFACTURING, DESIGN AND REPROCESSING RELATED. RATIONALE: INVESTIGATIONS LED TO THE ASSUMPTION THAT THE BREAKAGE WAS CAUSED BY STRESS-CORROSION CRACKING. WE ASSUME PRE-DAMAGE DUE TO A MANUFACTURING ERROR BY UNFAVOURABLE PRODUCTION-RELATED CIRCUMSTANCES, SUCH AS SHARP-EDGED MILLING TRANSITIONS, AS WELL AS CRITICAL MATERIAL TENSILE STRESS CONDITIONS DUE TO STRAIGHTENING WORK. WE ALSO ASSUME THAT THE DISCOLORATIONS ARE SIGNS OF AN OLD CRACK. THERE IS THE POSSIBILITY THAT THE VISIBLY DAMAGED TOOTH TIPS WERE CAUSED DUE TO A MANUFACTURING ERROR BY STRAIGHTENING WORK. DUE TO THE EXISTING PRE-DAMAGE OR WEAK POINT, THE REPROCESSING WAS FRACTURE-TRIGGERING. WE ASSUME THAT THE CRACKS ARE FERRITE RUSTICATES/FERRITE MICROSTRUCTURES. THE MICROSTRUCTURE, CHEMICAL COMPOSITION, HARDNESS AND MATERIAL TOUGHNESS COMPLY WITH THE SPECIFICATIONS. THE MATERIAL AS WELL AS THE HEAT TREATMENT CAN BE EXCLUDED AS CAUSE OF DAMAGE/BREAKAGE. VARIOUS TESTS ARE CARRIED OUT TO DERIVE MEASURES TO PREVENT AND OR MINIMIZE MATERIAL BREAKAGE. IN ADDITIONAL TO THE BOILING STRESS TEST, A TEST PLAN WAS ALSO PREPARED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE INSTRUMENT INTRAOPERATIVELY. DURING AN AORTIC VALVE REPLACEMENT SURGERY, THE CLAMP FRACTURED AT THE JAW WHILE PULLING A SUTURE. THERE WAS A SURGICAL DELAY OF ABOUT 20 MINUTES WHILE OTHER INSTRUMENTS WERE PROVIDED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414745 KELLY FORCEPS DEL CVD 140MM BASIC INSTRUMENTS HRQ AESCULAP AG BH135R 4509508222

    Patients

    Seq Age Sex Outcome Treatment
    1