BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 4120819 · Received July 28, 2014

    Report

    Report Number
    1717344-2014-00643
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER ORIGINALLY REPORTED THAT THE KNIFE BLADE WOULD NOT RETRACT AFTER THE JAWS WERE OPENED DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY. THERE WAS NO PATIENT INJURY. THE DEVICE WAS RETURNED FOR EVALUATION AND VISUAL INSPECTION DISCOVERED THAT WEBBING WAS PROTRUDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440020 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 243089X

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR