BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 3070984 · Received April 1, 2013

    Report

    Report Number
    3006451981-2013-00062
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 8, 2013
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED DEVICE WAS RETURNED FOR EVALUATION. THE JAWS WERE NOT STUCK SHUT. THE HANDLE WAS LATCHED AND UNLATCHED TEN TIMES WITH NO PROBLEM. THE DEVICE WAS ACTIVATED ON SIMULATED TISSUE WITH ACCEPTABLE RESULTS AND A VISUAL SEAL WAS OBSERVED. ADDITIONAL FUNCTIONAL TESTING WAS PERFORMED ON PORCINE KIDNEY TISSUE. MULTIPLE SEALS ON VARIOUS SIZE VESSELS WERE MADE AND ALL SEAL CYCLES COMPLETED SATISFACTORILY. THE JAWS WERE RELEASED FROM THE TISSUE WITH NO DIFFICULTY AND NO STICKING WAS OBSERVED. A SPRING COMPRESSION TEST, WHICH CORRELATES TO JAW FORCE, WAS PERFORMED AND THE RESULTS WERE WITHIN SPECIFICATION. COVIDIEN QA COULD NOT CONFIRM THE CUSTOMER'S REPORT. TO MINIMIZE TISSUE STICKING KEEP THE JAWS OF THE INSTRUMENT CLEAN AT ALL TIMES; CLEAN THE INSTRUMENT MORE OFTEN WHEN WORKING IN A BLOOD FIELD. IF CONSISTENT STICKING IS ENCOUNTERED, REDUCE THE BAR SETTING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A LAPAROSCOPIC OOPHORECTOMY-SALPINGECTOMY PROCEDURE, AFTER THE FIRST SEALING AND CUT WERE COMPLETED SUCCESSFULLY ON THE OVARIAN LIGAMENT, THE JAWS OF THE DEVICE WOULD NOT OPEN BACK UP AND RELEASE FROM THE TISSUE. THE SURGEON USED A NON-COVIDIEN DEVICE TO SEAL AND CUT THE AREA AROUND THE JAMMED JAWS TO RELEASE THE COVIDIEN DEVICE. IT CAUSED ALMOST NO BLEEDING, BUT A SLIGHT OOZING OCCURRED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131294 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING DEVICE GEI COVIDIEN LLC (SHANGHAI) S2C0048X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK