BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BI-POLAR CAUTERY

    MDR report key: 4797889 · Received May 5, 2015

    Report

    Report Number
    4797889
    Event Type
    Malfunction
    Date Received
    May 5, 2015
    Date of Event
    April 24, 2015
    Report Date
    May 5, 2015
    Manufacturer
    AESCULAP IMPLANT SYSTEMS, LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    THE KLEPPINGER BIPOLAR CAUTERY DID NOT FUNCTION CORRECTLY. THE CORD WAS REPLACED AND IT STILL DID NOT WORK. THE SURGEON DECIDED TO USE AN ALTERNATIVE DEVICE. DEVICE IDENTIFYING DATA WAS NOT ENTERED INTO EVENT REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293872 BI-POLAR CAUTERY FORCEPS, GENERAL & PLASTIC SURGERY GEI AESCULAP IMPLANT SYSTEMS, LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR