BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERAMIC ELECTRODE TIP J-HK F/GK372R

    MDR report key: 14877311 · Received June 30, 2022

    Report

    Report Number
    9610612-2022-00187
    Event Type
    Injury
    Date Received
    June 30, 2022
    Date of Event
    May 13, 2022
    Report Date
    August 30, 2022
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    PMA / PMN Number
    K970541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    INVESTIGATION: WE MADE A VISUAL INSPECTION OF THE RECEIVED ELECTRODE, ESPECIALLY THE FRACTURE SURFACE. THE FRACTURE SURFACES EXHIBIT THE TYPICAL SIGNS OF A MULTI AXIAL STRESS CONDITION OF BENDING AND TORSION. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS (DHR) HAVE BEEN CHECKED FOR ALL LEADING DEVICE(S) LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE ARE NO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER(S) WITH THIS ERROR PATTERN. THE REVIEW OF RISK ASSESSMENT REVEALED THAT THE OVERALL RISK LEVEL ((4)5 SEVERITY X (1)5 PROBABILITY OF OCCURRENCE) ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE. 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. BASED UPON THE INVESTIGATION RESULTS, A CAPA WAS NOT REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH GK383R - CERAMIC ELECTRODE TIP J-HK F/GK372R. ACCORDING TO THE COMPLAINT DESCRIPTION, THE TIP DETACHED UPON TROCAR REMOVAL. THIS OCCURRED DURING A LAPAROSCOPIC BILATERAL INGUINAL HERNIA PROCEDURE. AN ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THERE WAS AN UNKNOWN SURGICAL DELAY AND X-RAYS WERE TAKEN. LAPARASCOPIC INTRA-ABDOMINAL EXPLORATION WAS ALSO PERFORMED AND THE TROCAR WAS EXAMINED. THE FRAGMENT WAS NOT FOUND. 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
    1028730 CERAMIC ELECTRODE TIP J-HK F/GK372R HANDHELD PRODUCTS & LIGATION GEI AESCULAP AG GK383R 52556045

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Unknown Required Intervention