BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE V SEALER/DIVIDER

    MDR report key: 1904208 · Received November 15, 2010

    Report

    Report Number
    1717344-2010-00839
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    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 INITIALLY REPORTED THAT THE DEVICE INSULATION WAS STRIPPED WHEN GOING INTO THE TROCAR. THE SURGEON STATED HE BELIEVED THE PROBLEM WAS TORQUE. THE CUSTOMER REMOVED THE HANDPIECE FROM THE TROCAR WITH NO ILL EFFECT TO THE PT. THE INCIDENT DEVICE WAS RETURNED AND A VISUAL INSPECTION REVEALED THAT THE INSULATION ON THE SHAFT WAS SCRAPED AWAY, LEAVING OVER 1 INCH OF METAL EXPOSED NEAR THE JAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE V SEALER/DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 157240

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK