BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE V SEALER/DIVIDER

    MDR report key: 1818896 · Received August 24, 2010

    Report

    Report Number
    3006451981-2010-00068
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 30, 2010
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) . A VISUAL EXAMINATION OF THE INCIDENT DEVICE REVEALED BLOOD RESIDUE BETWEEN THE JAWS AND INSIDE THE HANDLE BODY. THE DEVICE HANDLE WAS LATCHED CLOSED AS RECEIVED. ALTHOUGH DIFFICULT TO OPEN, THE HANDLE COULD BE RELEASED BY SNAPPING THE LATCH, ALLOWING IT TO DISLODGE FROM THE INTERNAL TRACK. THIS CONDITION IS CONSISTENT WITH THE SKI GUIDE PRONGS GETTING CAUGHT ON THE INTERNAL A-TRACK. THE SKI GUIDE IS A FLEXIBLE PIECE THAT CAN BEND IF TOO MUCH FORCE IS APPLIED OR IF THE DEVICE IS LATCHED WHEN NOT IN USE. THE TWO PRONGS THAT GUIDE THE SKI CAN COME OUT OF PERPENDICULAR ALIGNMENT WITH THE A-TRACK AND THE LATCH CANNOT BE RELEASED. MFG IS REQUIRED TO LATCH AND UNLATCH THE INSTRUMENT THREE TIMES TO CHECK FOR PROPER FUNCTION PRIOR TO ACCEPTING THE PRODUCT. IF THE LATCH WAS NOT WORKING PROPERLY AT THIS TIME, THE INSTRUMENT WOULD NOT HAVE PASSED COVIDIEN'S FUNCTIONAL TESTING. NO TREND HAS BEEN IDENTIFIED FOR THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE JAWS FAILED TO OPEN HALFWAY THROUGH THE PROCEDURE. ALTHOUGH NO FURTHER INFO HAS BEEN MADE AVAILABLE AS TO HOW THE DEVICE WAS REMOVED FROM TISSUE, THE SITE DID INDICATE THAT A SMALL AMOUNT OF BLEEDING RESULTED WHEN THE DEVICE WAS REMOVED. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE V SEALER/DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S0AB009

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK