BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLE ELECTRODE MONO Ø 5MM WL 340MM

    MDR report key: 18793565 · Received February 27, 2024

    Report

    Report Number
    9611102-2024-00007
    Event Type
    Injury
    Date Received
    February 27, 2024
    Date of Event
    January 25, 2024
    Report Date
    February 27, 2024
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GEI
    PMA / PMN Number
    K964329
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS SHOWN THAT THE AFFECTED DEVICE, TYPE 8383.426, WAS SUBJECTED TO A THIRD -PARTY REPAIR BY MEDWORX GMBH. IN THIS THIRD-PARTY REPAIR, A DIFFERENT INSULATION MATERIAL AND A DIFFERENT PLUG WERE USED. THESE FACTS DO NOT CORRESPOND TO THE DESIGN OF THE NEEDLE ELECTRODE MONO 0 5MM NL 340MM, TYPE 8383.426 FROM RICHARD WOLF GMBH. THEREFORE WE, RICHARD WOLF GMBH, CANNOT MAKE ANY FURTHER EVALUATIONS OR OTHER STATEMENTS. MEDWORX GMBH IS NOT AUTHORIZED BY RICHARD WOLF (RW) TO CARRY OUT REPAIRS OR SERVICE ON RW PRODUCTS. THIS WAS AN UNAUTHORIZED REPAIR. THE PRODUCT NO LONGER COMPLIES WITH THE RW SPECIFICATIONS AND IS THEREFORE TO BE TREATED AS A THIRD-PARTY PRODUCT WITHIN THE SCOPE OF THE EU MDR (MDCG2O23-3).

    Description of Event or Problem · 0

    ON 29/JAN/2024, RICHARD WOLF GMBH (RWGMBH) WERE INFORMED BY THE FEDERAL INSTITUTE FOR DRUGS AND MEDICAL DEVICES (BUNDESINSTITUT FÜR ARZNEIMITTEL UND MEDIZINPRODUKTE, BFARM) ABOUT A USER REPORT FROM THE "KLINIKUM ST. MARIEN AMBERG". BFARM CASE NUMBER: (B)(4). THE ISSUE IS IN REGARDS WITH A NEEDLE ELECTRODE MONO Ø 5MM WL 340MM, PART ID: 8383.426, BATCH# 1468475. ACCORDING TO THE REPORT, WHEN USING THE MONOPOLAR HOOK, THE INSULATION FELL OFF DURING "STROBING". PARTS OF THE INSULATION COULD BE REMOVED FROM THE ABDOMINAL CAVITY, BUT IT IS NOT 100% CERTAIN THAT ALL OF IT WAS ACTUALLY REMOVED. THERE WAS NO INJURY FOR PATIENT OR OTHER PERSONAL. THE TREATMENT COULD BE COMPLETED WITHOUT CRITICAL TIME DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444838 NEEDLE ELECTRODE MONO Ø 5MM WL 340MM GEI RICHARD WOLF GMBH 8383426 1468475

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other