BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 20CM

    MDR report key: 3060508 · Received March 26, 2013

    Report

    Report Number
    3006451981-2013-00071
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 6, 2013
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED DEVICE WAS RETURNED FOR EVALUATION. THE KNIFE BLADE WAS NOT STUCK IN THE EXTENDED POSITION, NOR WAS IT OFF ITS TRACKS. QA COULD NOT CONFIRM THE CUSTOMER'S REPORT OF THE KNIFE BLADE NOT RETRACTING. THE JAWS WERE CLEANED AND THE DEVICE FUNCTIONED NORMALLY. THE HANDLE WAS LATCHED AND UNLATCHED TEN TIMES WITH NO PROBLEM. THE KNIFE EXTENDED AND RETRACTED NORMALLY. THE KNIFE CUT OFF THE DEVICE WAS TESTED ON A SILICONE TEST STRIP WITH ACCEPTABLE RESULTS. NO DAMAGE TO THE BLADE WAS EVIDENT UNDER MAGNIFICATION. WHEN THE JAWS WERE TESTED ON A SILICONE STRIP, THE JAWS OPENED WITHOUT DIFFICULTY. THE REPORTED EVENT IS ATTRIBUTED TO INFREQUENT OR IMPROPER CLEANING OF THE DEVICE. TO MINIMIZE TISSUE STICKING, KEEP THE JAWS CLEAN, AND CLEAN THE INSTRUMENT MORE OFTEN WHEN WORKING IN A BLOODING FIELD.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER A NORMAL USE DURING AN OVARIECTOMY, THE SURGEON AGAIN APPLIED THE DEVICE TO THE OVARY BUT WAS NOT ABLE TO CUT AS THE BLADE WENT OFF ITS TRACKS. AT THE SAME TIME, THE HANDLE LOCKED AND IT WS DIFFICULT TO REMOVE THE INSTRUMENT FROM TISSUE. AFTER A FEW MINUTES, THEY WERE ABLE TO REMOVE THE INSTRUMENT BY CUTTING IT FROM THE TISSUE. THERE REPORTEDLY WAS NO STAPLE OR OTHER METAL OBJECT ENCLOSED IN THE LIGASURE'S JAWS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123053 LIGASURE ATLAS HANDSWITCHING 20CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S2E0023X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK