BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RICHARD WOLF

    MDR report key: 1983624 · Received February 4, 2011

    Report

    Report Number
    MW5019314
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 4, 2011
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGEON USING WOLF INSULATED HOOK ENDOSCOPICALLY ON FASCIA FOR ADHESIONS AT 40/40 SETTING ON THE BOVIE. ONCE HOOK IN DECONTAMINATION ROOM, NOTICED MELTING OF THE INSULATION ON THE TIP. TO DATE, NO UNTOWARD OUTCOME WITH PATIENT. THIS PRODUCT WAS BOUGHT FROM (B)(4) ON (B)(6) 2011 AND WE BOUGHT 6 OF THEM. ALL 6 HAVE BEEN SEQUESTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RICHARD WOLF MONOPOLAR INSULATED L HOOK 5MM-340MM GEI RICHARD WOLF MEDICAL INSTRUMENTS L HOOK 146D10

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Disability