BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 20CM

    MDR report key: 4861953 · Received June 23, 2015

    Report

    Report Number
    3006451981-2015-00148
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    June 23, 2015
    Report Date
    May 29, 2015
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF FOLLOW-UP REPORT : (B)(6) 2015. THE DEVICE WAS ACTIVATED MULTIPLE TIMES ON SIMULATED TISSUE WITH ACCEPTABLE RESULTS. THE JAWS OPENED AND CLOSED NORMALLY USING THE HANDLE. THE KNIFE EXTENDED AND RETRACTED NORMALLY USING THE TRIGGER. THE INVESTIGATION FOUND THE DEVICE TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS.

    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 THE DEVICE JAWS WOULD NO LONGER OPEN AFTER BEING APPLIED TO PATIENT TISSUE. THE JAWS WERE REMOVED BY SURGICAL SCISSORS CUTTING ADJACENT TISSUE. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406753 LIGASURE ATLAS HANDSWITCHING 20CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN MEDICAL PRODUCTS (SHANGHAI) S4E0006X

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR