BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CORD

    MDR report key: 7393978 · Received April 3, 2018

    Report

    Report Number
    3000719969-2018-00005
    Event Type
    Malfunction
    Date Received
    April 3, 2018
    Date of Event
    March 6, 2018
    Report Date
    March 30, 2018
    Manufacturer
    OLSEN MEDICAL LLC
    Product Code
    GEI
    PMA / PMN Number
    K130669
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON GOT A SMALL BURN ON HIS RIGHT HAND FROM USING A HOOK CAUTERY INSTRUMENT WITH AN ELECTRO-SURGICAL UNIT (ESU) CORD THAT FRACTURED. THE BURN WAS ABOUT 3 MM IN DIAMETER AT THE BASE OF HIS RIGHT THUMB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234324 MONOPOLAR CORD UNIPOLAR BOVIE CORD W-UNIVERSAL PLUG GEI OLSEN MEDICAL LLC 88-9199

    Patients

    Seq Age Sex Outcome Treatment
    1