BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORO® NON-STICK BIPOLAR FORCEPS

    MDR report key: 8158950 · Received December 13, 2018

    Report

    Report Number
    3003923584-2018-00064
    Event Type
    Malfunction
    Date Received
    December 13, 2018
    Date of Event
    September 25, 2018
    Report Date
    November 7, 2018
    Manufacturer
    PRO MED INSTRUMENTS GMBH
    Product Code
    GEI
    PMA / PMN Number
    K070997
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IN THIS FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE DEVICE IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    CUSTOMER STATED: "FORCEPS HEAT UP IN USE. BURNS ON HANDS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999552 DORO® NON-STICK BIPOLAR FORCEPS DORO® NON-STICK BIPOLAR FORCEPS GEI PRO MED INSTRUMENTS GMBH 5062.012 170714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention