BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOWA RETURN ELECTRODE

    MDR report key: 17415511 · Received July 26, 2023

    Report

    Report Number
    MW5120278
    Event Type
    Injury
    Date Received
    July 26, 2023
    Report Date
    May 26, 2023
    Manufacturer
    BOWA-ELECTRONIC GMBH & CO. KG
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PER CNF, IT WAS REPORTED THAT: A BOWA 818-162 RETURN ELECTRODE WAS BEING USED. THE DEVICE HAD PREVIOUSLY BEEN USED WITHOUT ANY PROBLEM, BUT FOR THE FIRST TIME TODAY, IT COULD NOT BE RECOGNIZED. THEREFORE, THE DEVICE WAS REPLACED WITH A SINGLE TYPE RETURN ELECTRODE AND THE PROCEDURE WAS PERFORMED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B) (2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795868 BOWA RETURN ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOWA-ELECTRONIC GMBH & CO. KG 818-162

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention