BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 4355702 · Received December 1, 2014

    Report

    Report Number
    3006451981-2009-00026
    Event Type
    Injury
    Date Received
    December 1, 2014
    Date of Event
    September 17, 2009
    Report Date
    October 5, 2009
    Manufacturer
    COVIDIEN LLC
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL INFO IN REGARD TO THE INCIDENT HAS ALSO BEEN REQUESTED. 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 THROUGH A MEDWATCH FORM, THAT THE MASS WITHIN THE ADRENAL GLAND AND THE VENA CAVA WERE IDENTIFIED. THEN THE DEVICE WAS USED TO SEAL THE ADRENAL VEIN. AFTER THE PHYSICIAN RECEIVED AN END TONE INDICATING THAT THE VEIN HAD BEEN LIGATED, THE ADRENAL VEIN WAS CUT. WHEN THE DEVICE WAS RELEASED, THERE WAS SEVERE BLEEDING FROM THE ADRENAL VEIN. THE PROCEDURE WAS THEN CONVERTED TO AN OPEN ADRENALECTOMY AND A RIGHT NEPHRECTOMY WAS PERFORMED. NO ADDITIONAL INFO HAS BEEN PROVIDED BY THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774290 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYS GEI COVIDIEN LLC S9G0015

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other