BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 1935689 · Received December 16, 2010

    Report

    Report Number
    1717344-2010-00964
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 24, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN REC'D AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULATED SLEEVE ON THE DEVICE ROLLED OFF WHEN THE INSTRUMENT WAS BEING PULLED THROUGH THE TROCAR. THE INSULATION WAS RETRIEVED FROM THE PT ABDOMEN. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 192163

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK