BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 3474550 · Received October 8, 2013

    Report

    Report Number
    3006451981-2013-00321
    Event Type
    Malfunction
    Date Received
    October 8, 2013
    Date of Event
    September 10, 2013
    Report Date
    September 17, 2013
    Manufacturer
    COVIDIEN LLC (SHANGHAI) BLDG 10, 789 PUXING RD
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN OPEN GASTRECTOMY PROCEDURE, THE JAWS OF THE DEVICE WOULD NOT REOPEN WHILE APPLIED TO TISSUE. THE SURGEON USED OTHER INSTRUMENTS TO APPLY EXTRA FORCE AT THE JAWS IN ORDER TO REMOVE THE DEVICE FROM THE TISSUE. THERE WAS NO TISSUE TRAUMA OR INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510314 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) BLDG 10, 789 PUXING RD S2C0017X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK