BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-CWE CUTTING ELECTRODE

    MDR report key: 8866110 · Received August 5, 2019

    Report

    Report Number
    MW5088816
    Event Type
    Injury
    Date Received
    August 5, 2019
    Date of Event
    July 17, 2019
    Report Date
    July 19, 2019
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ELECTROCAUTERY LOOP BROKE DURING PROCEDURE UNABLE TO DETERMINE IF ALL PIECES WERE STILL PRESENT. SURGEON DID A VISUAL INSPECTION TO EXAMINE THE ENTRY AND TO LOCATE ANY MISSING PIECES. NONE WER FOUND OR VISUALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656997 S-CWE CUTTING ELECTRODE ELECTROSURGICAL, CUTTING, COAGULATION, ACCESSORIES GEI RICHARD WOLF GMBH 4622.1313 51015519

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention