BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TONSIL AND ADENOID HANDPIECE

    MDR report key: 3224304 · Received July 8, 2013

    Report

    Report Number
    MW5030849
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 8, 2013
    Manufacturer
    MEDICAL ENERGY INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LASER PROBE TIP FROM MEDICAL ENERGY BROKE OFF WHILE USING IT DURING A SURGICAL PROCEDURE -TONSILLECTOMY AND ADENOIDECTOMY. REASON FOR USE: TONSILLECTOMY/ADENOIDECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308609 TONSIL AND ADENOID HANDPIECE LASER TIP PROBE GEI MEDICAL ENERGY INC 1063C

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR TIP STYLE 2.5 BALL