BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE

    MDR report key: 7673093 · Received July 10, 2018

    Report

    Report Number
    7673093
    Event Type
    Malfunction
    Date Received
    July 10, 2018
    Date of Event
    June 27, 2018
    Report Date
    July 2, 2018
    Manufacturer
    ERBE USA, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INTRAOPERATIVE POLYP TO BE REMOVED WITH HOT SNARE. UPON DEPRESSING ERBE PEDAL, LINES NOTED ON DISPLAY MONITOR FOLLOWED BY MOMENTARY SCREEN BLACKOUT. DOCTOR DESCRIBED INCREASED AREA OF CAUTERY MORE THAN EXPECTED. NO HARM TO PATIENT. MACHINE REMOVED FROM SERVICE. ERBE SETTINGS: 1 SNARE HBX; ENDOCUT Q 3; FORCED COAG 3/25; BIOMED NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517313 ERBE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ERBE USA, INC. 10140-400

    Patients

    Seq Age Sex Outcome Treatment
    1 18980 DA