BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERAMIC ELECTRODE TIP L-HK F/GK372R

    MDR report key: 12657100 · Received October 19, 2021

    Report

    Report Number
    9610612-2021-00657
    Event Type
    Malfunction
    Date Received
    October 19, 2021
    Date of Event
    September 21, 2021
    Report Date
    May 3, 2022
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    UDI-DI
    04038653172504
    PMA / PMN Number
    K970541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: AS OF THE DATE OF THIS REPORT THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. THEREFORE, A THOROUGH INVESTIGATION IS NOT POSSIBLE. BATCH HISTORY REVIEW: DUE TO THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL, MANUFACTURING OR DESIGN-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT PRODUCT WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATION RESULTS A CAPA IS NOT NECESSARY.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH GK384R - CERAMIC ELECTRODE TIP L-HK F/GK372R. ACCORDING TO THE COMPLAINT DESCRIPTION, THE INSTRUMENT BROKE DURING LAPAROSCOPIC CHOLECYSTECTOMY SURGERY. THE L- HOOK BROKE DURING SURGERY; AND THE BREAKAGE WAS NOT FOUND UNTIL THE INSTRUMENT MADE IT TO STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1556160 CERAMIC ELECTRODE TIP L-HK F/GK372R REUSABLE INSTRUMENTS GEI AESCULAP AG GK384R 04038653172504

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown