BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 3944204 · Received May 7, 2014

    Report

    Report Number
    1717344-2014-00402
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Report Date
    April 14, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE#: (B)(4). THE SITE HAS INDICATED THAT THE INCIDENT SAMPLE HAS BEEN DISCARDED. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CLEAR INSULATION STARTED TO COME OFF OF THE DEVICE. THERE WAS NO PATIENT INJURY. THE SITE DISCARDED THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274965 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 40300223X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK