BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 1922012 · Received December 8, 2010

    Report

    Report Number
    1717344-2010-00936
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 25, 2010
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: 12/08/2010. THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE IT HAS NOT BEEN RECEIVED FOR EVAL. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SOMETIME AT THE END OF (B)(6) OR THE BEGINNING OF (B)(6) DURING A PROCEDURE THE INSTRUMENT CUT BUT DID NOT SEAL. IT DID NOT SEEM TO SEAL IN THE BEGINNING OF THE PROCEDURE WHEN IT WAS USED ON THE PERITONEUM, BUT SINCE IT DID NOT BLEED IN EXCESS, THE SURGEON CONTINUED WITH THE PROCEDURE. WHEN HE STARTED WORKING ON THE LOWER MESENTERIC VEIN, A HEMORRHAGE OCCURRED THAT THE SURGEON FIXED WITH PINCERS WHILE ANOTHER LS1037 WAS OPENED, WHICH SEALED WITHOUT FURTHER ISSUES. THERE WAS TISSUE INJURY ON THE LOWER MESENTERIC VEIN. THERE WAS NO BLEEDING IN EXCESS OF 250CC. THERE WAS A DELAY OF 45 MINUTES. THE PT IS CURRENTLY IN GOOD CONDITION. A FORCE TRIAD GENERATOR WAS IN USE WITH THE DEVICE AND WAS SET AT 3 BARS. AN END TONE, INDICATING A COMPLETED SEAL CYCLE, WAS PROVIDED BY THE GENERATOR. THE VESSELS WERE DESCRIBED AS BEING APPROXIMATELY .05MM. THE MESENTERIC VEIN WAS REPAIRED USING AN ENDOGIA VASCULAR DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK