BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISP EXTENDER 3" GSU

    MDR report key: 3057803 · Received March 22, 2013

    Report

    Report Number
    1717344-2013-00220
    Event Type
    Malfunction
    Date Received
    March 22, 2013
    Report Date
    March 8, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION OF THE INCIDENT SAMPLE FOUND ESCHAR IN THE TUBE AND ON THE OUTSIDE OF THE DEVICE. THE SAMPLE WAS BENT AND THE INSULATION WAS SPLIT AND MELTED. THE SAMPLE FAILED HIPOT TESTING. THE DAMAGE WAS MOST LIKELY CAUSED BY THE ACCUMULATION OF ESCHAR AND THE HIGH OUTPUT SETTINGS DURING USE. THE INSTRUCTIONS FOR USE RECOMMEND STARTING AT VERY LOW OUTPUT SETTINGS AND CAUTIOUSLY INCREASING THE POWER UNTIL THE DESIRED EFFECT IS ACHIEVED. THE ELECTRODE SHOULD BE WIPED CLEAN DURING USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A THORACIC PROCEDURE, THE TIP OF THE EXTENDER MELTED. NOTHING FELL INTO THE PT CAVITY. THERE WAS NO PT INJURY. THE CONCOMITANT FORCEFXC GENERATOR WAS SET AT 120 WATTS. THE SITE BIOMED TESTED THE GENERATOR FOLLOWING THE PROCEDURE AND FOUND IT TO FUNCTION PROPERLY. THE INCIDENT DEVICE FAILED HIPOT TESTING DURING INITIAL EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119348 DISP EXTENDER 3" GSU ES ACCESSORY GEI COVIDIEN LP 224695X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK FORCE FXC GENERATOR, S/N UNK