BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE SUCTION COAGULATOR

    MDR report key: 17407126 · Received July 25, 2023

    Report

    Report Number
    MW5120185
    Event Type
    Malfunction
    Date Received
    July 25, 2023
    Date of Event
    July 3, 2023
    Report Date
    July 21, 2023
    Manufacturer
    A&E MEDICAL CORPORATION / ALTO DEVELOPMENT CORP.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE PHYSICIAN WAS USING THE SUCTION BOVIE DURING A T&A (TONSILLECTOMY AND ADENOIDECTOMY), THE BOVIE CAME APART. SHE WAS ABLE TO RECONNECT IT AND CONTINUE TO USE IT WITHOUT ISSUE. SHE INSPECTED PT'S (PATIENT'S) OROPHARYNX AND DID NOT SEE ANY INJURY. HANDPIECE AND PACKAGING WERE SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1467329 DISPOSABLE SUCTION COAGULATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI A&E MEDICAL CORPORATION / ALTO DEVELOPMENT CORP. 05635

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Female Other