BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 4171602 · Received October 14, 2014

    Report

    Report Number
    3006451981-2014-00755
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 19, 2014
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED DEVICE WAS RETURNED AND EVALUATED. VISUAL INSPECTION FOUND NO DEFECTS. THE DEVICE WAS ACTIVATED ON SIMULATED TISSUE WITH ACCEPTABLE RESULTS AND A VISUAL SEAL EFFECT WAS OBSERVED. FURTHER FUNCTIONAL TESTING WAS PERFORMED ON PORCINE KIDNEY TISSUE. MULTIPLE SEALS ON VARIOUS SIZE VESSELS WERE MADE IN AN ATTEMPT TO DUPLICATE THE CUSTOMER'S COMPLAINT. ALL SEAL CYCLES COMPLETED SATISFACTORILY. THE INVESTIGATION FOUND THE DEVICE TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS. A DEVICE HISTORY REVIEW WAS COMPLETED AND NO ENTRIES PERTINENT TO THE CUSTOMER'S REPORT WERE NOTED. COVIDIEN COULD NOT CONFIRM THE CUSTOMER'S REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION 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 LAPAROSCOPIC HYSTERECTOMY, THE DEVICE FAILED TO SEAL. REPORTEDLY, AN ENDTONE HAD BEEN HEARD (INDICATING A COMPLETED SEAL CYCLE). WHEN THE SURGEON CUT THE TISSUE, BLEEDING OCCURRED THAT MADE IT DIFFICULT TO VISUALIZE THE SURGICAL FIELD. THE AMOUNT OF BLOOD LOSS IS UNKNOWN BUT WAS DESCRIBED AS LESS THAN 500CC. THE SURGEON CONVERTED TO AN OPEN PROCEDURE, AND THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650019 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) LS1037 S4E0017X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R