BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 3190815 · Received June 14, 2013

    Report

    Report Number
    3006451981-2013-00190
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 1, 2013
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REQUESTED BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE JAWS OF THE DEVICE COULD NOT BE REOPENED WHILE APPLIED TO TISSUE. SUTURES WERE USED TO STITCH BOTH SIDES OF THE SEALED AREA, AND THE SURGEON RESECTED THE TISSUE DIRECTLY ADJACENT TO THE JAWS IN ORDER TO REMOVE THE DEVICE FROM THE TISSUE. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272306 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S2E0032PX

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR