BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMMETRY OLSEN

    MDR report key: 12851502 · Received November 22, 2021

    Report

    Report Number
    12851502
    Event Type
    Malfunction
    Date Received
    November 22, 2021
    Date of Event
    October 12, 2021
    Report Date
    October 14, 2021
    Manufacturer
    OLSEN MEDICAL, LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    AT THE BEGINNING OF THE PROCEDURE, IT WAS DISCOVERED THAT THE TIPS OF THE DISPOSABLE BIPOLAR CROSSED. PER DR., THIS IS BECOMING MORE COMMON. WHEN USING THE BIPOLAR AND THE TIPS CROSS, THERE IS AN INCREASED RISK FOR DAMAGE TO THE SURROUNDING TISSUES AND OTHER SURGICAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749889 SYMMETRY OLSEN ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI OLSEN MEDICAL, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 13505 DA Female