BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE MONOPOLAR PROBE

    MDR report key: 15527699 · Received September 30, 2022

    Report

    Report Number
    MW5112363
    Event Type
    Malfunction
    Date Received
    September 30, 2022
    Date of Event
    September 27, 2022
    Report Date
    September 28, 2022
    Manufacturer
    TECHNOMED EUROPE
    Product Code
    GXZ
    UDI-DI
    08718375866313
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN REMOVING PROBE FROM METAL SHEATH, DR NOTICED THE PROBE SHEATH WAS MISSING. ALL PIECES RETRIEVED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1417939 DISPOSABLE MONOPOLAR PROBE ELECTRODE, NEEDLE GXZ TECHNOMED EUROPE MP214-3.0/1 053433 08718375866313

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown Other