BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISP BIPOLAR FORCEPS CORD

    MDR report key: 3122587 · Received May 17, 2013

    Report

    Report Number
    1717344-2013-00361
    Event Type
    Injury
    Date Received
    May 17, 2013
    Report Date
    April 26, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SITE HAS INDICATED THE INCIDENT SAMPLE WILL NOT BE RETURNED TO COVIDIEN FOR EVAL. ADD'L QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED. IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SURGEON WAS USING THE BIPOLAR CORD WITH KIRWIN AND LIFE INSTRUMENT FORCEPS DURING A SPINE PROCEDURE. THE SURGEON STARTED TO GET INTERMITTENT POWER TO THE DEVICES. THE PROCEDURE WAS STOPPED DUE TO THE INTERMITTENT FUNCTION OF THE DEVICES AND THE PT WENT BACK TO SURGERY THE NEXT DAY. THE SITE REPORTED THE INCIDENT CORD WILL NOT BE RETURNED TO COVIDIEN FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219746 DISP BIPOLAR FORCEPS CORD DISPOSABLE BIPOLAR FORCEPS CORD GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other