BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20X12MM DISP TNG LLETZ LOOP

    MDR report key: 1983255 · Received February 2, 2011

    Report

    Report Number
    1717344-2011-00073
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 20, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE, HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE SETTINGS USED WERE SIGNIFICANTLY OVER THE IFU RECOMMENDED SETTING OF 30 W COAG. A COVIDIEN REP HAS NOTIFIED THE SITE AND SENT THEM A COPY OF THE IFU RECOMMENDATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A CERVICAL BIOPSY, THE ELECTRODE MELTED. SOME OF THE MELTED BLUE INSULATION FELL ONTO THE SURGICAL SITE BUT WAS RETRIEVED WITH FORCEPS. THERE WAS NO PT INJURY. THE GENERATOR WAS SET AT 64 COAG AND 100 CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 20X12MM DISP TNG LLETZ LOOP ELECTROSURGICAL ACCESSORY GEI COVIDIEN LP (VALLEYLAB) BOULDER UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Life Threatening FORCEFX, ELECTROSURGICAL GENERATOR - S/N (B)(4)