BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 2000135 · Received February 18, 2011

    Report

    Report Number
    3006451981-2011-00040
    Event Type
    Malfunction
    Date Received
    February 18, 2011
    Date of Event
    November 1, 2010
    Report Date
    February 14, 2011
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE IT HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A SLEEVE GASTRECTOMY, THEY GOT AN END TONE, INDICATING A COMPLETED SEAL CYCLE, BUT THERE WAS BLEEDING. THEY OPENED A NEW DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S0F0009P

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR