BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 3983510 · Received June 26, 2014

    Report

    Report Number
    1717344-2014-00557
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    April 30, 2014
    Report Date
    June 1, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CLEAR INSULATION WAS DAMAGED. THE DEVICE FAILED HIPOT TESTING. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE JAW WOULD NOT OPEN WHILE NOT ON PATIENT TISSUE. THERE WAS NO INJURY TO THE PATIENT. THE DEVICE WAS RETURNED TO COVIDIEN AND VISUAL INSPECTION DISCOVERED THAT THE CLEAR INSULATION WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373865 LIGASURE ADVANCE PISTOL GRIP LIGASURE ADVANCE PISTOL GRIP GEI COVIDIEN LP 32900139X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK