BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 3063426 · Received March 28, 2013

    Report

    Report Number
    3006451981-2013-00068
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    February 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS SHANGHAI MANUFACTURING. LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED DEVICE WAS RETURNED FOR EVAL. VISUAL INSPECTION NOTED THE CORD HAD BEEN CUT OFF BY THE SITE. BECAUSE THE CORD HAD BEEN CUT OFF, FUNCTIONAL TESTING COULD NOT BE PERFORMED. THUS, COVIDIEN QA COULD NOT CONFIRM THE CUSTOMER'S REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LIGASURE DEVICE DID NOT SEEM TO SEAL PROPERLY FOR THE ENTIRE LENGTH OF A GASTRIC SLEEVE SURGERY. THE DEVICE WAS USED FOR THE DURATION OF THE PROCEDURE. MUCH OOZING OCCURRED THROUGHOUT THE CASE EVEN AFTER MULTIPLE ENDTONES (INDICATING COMPLETED SEAL CYCLES) WERE HEARD. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129199 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING DEVICE GEI COVIDIEN MEDICAL PRODUCTS SHANGHAI MANUFACTURING. LLC S2H0022PX

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR