BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 3063376 · Received March 28, 2013

    Report

    Report Number
    3006451981-2013-00067
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 7, 2013
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE SURGEON FUSED THE MESENTERY TISSUE, THE DEVICE WORKED ONLY INTERMITTENTLY. THE SURGEON TRIED TO FUSE SEVERAL TIMES BUT THE TISSUE WAS BLEEDING, SO HE OPENED A NEW DEVICE. END TONES WERE HEARD WHEN THE BLEEDING OCCURRED. THE DEVICE WAS USED TO STOP THE BLEEDING AND COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127319 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING DEVICE GEI COVIDIEN LLC (SHANGHAI) S2F0026X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK