BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 3882823 · Received February 20, 2014

    Report

    Report Number
    3006451981-2014-00514
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    October 30, 2013
    Report Date
    November 14, 2013
    Manufacturer
    COVIDIEAN LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE DEVICE WAS RETURNED AND EVALUATED. VISUAL INSPECTION FOUND NO RESIDUAL TISSUE INSIDE OF THE JAWS. THE JAWS WERE NOT STUCK SHUT AND THE HANDLE WAS LATCHED AND UNLATCHED WITHOUT DIFFICULTY. WHEN ACTIVATED ON PORCINE KIDNEY TISSUE, THE JAWS OPENED AND CLOSED NORMALLY; THE JAWS DID NOT STICK TO OR LOCK ONTO THE TISSUE. MULTIPLE SEALS ON VARIOUS SIZE VESSELS WERE MADE IN AN ATTEMPT TO DUPLICATE THE CUSTOMER'S COMPLAINT. ALL SEAL CYCLES COMPLETED SATISFACTORILY AND THE JAWS REOPENED WITHOUT DIFFICULTY OR LOCKING. THE INVESTIGATION FOUND THE DEVICE TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS. A DEVICE HISTORY REVIEW WAS COMPLETED AND NO ENTRIES PERTINENT TO THE CUSTOMER'S REPORT WERE NOTED. COVIDIEN COULD NOT CONFIRM THE CUSTOMER'S REPORT. INITIAL REPORT SENT UNDER MDR NUMBER 1717344-2013-00954.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT REOPEN WHILE APPLIED TO TISSUE. THE SURGEON REMOVED THE DEVICE BY PRYING IT OFF THE TISSUE WITH ANOTHER INSTRUMENT. THE SURGERY TIME WAS EXTENDED BY ONLY FIVE MINUTES. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107708 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEAN LLC S3D0022X

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR