BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERAMIC ELECTRODE TIP L-HK F/GK372R

    MDR report key: 11202582 · Received January 20, 2021

    Report

    Report Number
    9610612-2020-00989
    Event Type
    Malfunction
    Date Received
    January 20, 2021
    Date of Event
    November 4, 2020
    Report Date
    March 5, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    PMA / PMN Number
    K970541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4-UDI. 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 INVESTIGATIONS RESULTS THERE IS 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 DURING THE LAPAROSCOPIC CHOLECYSTECTOMY INTESTINAL ADHESION DECOMPOSITION SURGERY, THE ELECTRIC HOOK HEAD FELL OFF, IMMEDIATELY ACTIVATED THE EMERGENCY PLAN, SEARCH, POSTOPERATIVE FLUOROSCOPY, FOUND NO LEFT IN THE PATIENT, FOUND THE SHED PART. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100425 CERAMIC ELECTRODE TIP L-HK F/GK372R REUSABLE INSTRUMENTS GEI AESCULAP AG GK384R

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR