BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE ATLAS HANDSWITCHING 20CM

    MDR report key: 1783697 · Received July 30, 2010

    Report

    Report Number
    1717344-2010-00522
    Event Type
    Injury
    Date Received
    July 30, 2010
    Date of Event
    June 11, 2010
    Report Date
    July 8, 2010
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS DISCARDED AT THE SITE AND NO EVALUATION IS POSSIBLE. THE SITE HAS DECLINED TO GIVE ANY FURTHER PATIENT SPECIFIC INFORMATION. COVIDIEN LP (FORMERLY VALLEYLAB) PROVIDES AN ONLINE BULLETIN TO INFORM CUSTOMERS HOW TO AVOID TISSUE BUILDUP THAT CAN LEAD TO STICKING. THIS BULLETIN REITERATES INFORMATION PROVIDED IN THE IFU WHICH STATES THAT IF THE JAWS ARE NOT CLEANED AS INSTRUCTED, ESCHAR CAN BUILD UP AND CAUSE THE JAWS TO STICK TO THE SEALED TISSUE. THIS CAN LEAD TO DIFFICULTY IN OPENING AND CLOSING THE DEVICE. KEEP THE JAWS OF THE INSTRUMENT CLEAN AT ALL TIMES AND CLEAN THE INSTRUMENT MORE OFTEN WHEN WORKING IN A BLOODY FIELD. IF CONSISTENT STICKING IS ENCOUNTERED, REDUCE THE BAR SETTING. DO NOT RE-USE OR REPROCESS THE DEVICE AS THIS CAN DAMAGE THE SURFACE OF THE JAWS AND LEAD TO IMPROPER PERFORMANCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A TOTAL GASTRECTOMY WITH ROUX-EN-Y RECONSTRUCTION PROCEDURE, THE SURGEON EXPERIENCED STICKING WHILE TAKING SHORT GASTRIC VESSELS. THE SURGEON HAD TO FORCE THE HANDLES OPEN IN ORDER TO OPEN JAWS. THIS CAUSED TISSUE TO TEAR. THE SURGEON REPORTED THAT THE TECHNICIAN CLEANED THE DEVICE FREQUENTLY BECAUSE HE INITIALLY FELT THAT ESCHAR BUILDUP WAS CAUSING THE DIFFICULTY TO OPEN THE JAWS AND IT SEEMED LIKE THE CHAR WAS CAUSING THE JAWS TO STICK TOGETHER. SURGEON USED ANOTHER DEVICE TO SEAL THE TISSUE AND FELT THE BLEEDING WAS UNDER CONTROL. SEVERAL DAYS LATER, PATIENT HAD A RESPIRATORY INFECTION AND WAS READMITTED TO THE HOSPITAL. THE DOCTOR DID NOT SAY SPECIFICALLY THAT THE READMISSION WAS DUE TO THE LS1020, BUT HE DID BELIEVE THAT THE DIFFICULTIES HE HAD WITH THE INSTRUMENT CONTRIBUTED TO THE ISSUE. HE DID SAY THAT THE PATIENT WAS NOT A VERY HEALTHY PERSON AND THAT HE HAD MANY OTHER ISSUES OCCURRING AS WELL. THE GENERATOR WAS SET AT 2 BARS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O FORCETRIAD - ELECTROSURGICAL GENERATOR - S/N UNK