BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE V SEALER/DIVIDER

    MDR report key: 3709119 · Received February 18, 2014

    Report

    Report Number
    3006451981-2014-00187
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    October 6, 2010
    Report Date
    November 15, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED. THE JAWS OF THE INCIDENT DEVICE WERE LOCKED ON DRIED TISSUE. THE HANDLE WAS LATCHED AND COULD NOT BE RELEASED. THE SKI OF THE HANDLE WAS OUTSIDE OF THE A-TRACK. THE SKI PIN IS A FLEXIBLE PIECE THAT CAN BEND TO ACCOMMODATE LIGHT FORCE TO THE HANDLE. IF TOO MUCH FORCE IS APPLIED, THE PIN WILL JUMP OUT OF THE TRACK AND CAUSE THE HANDLE LATCH TO JAM. MANUFACTURING 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 FUNCTIONAL TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE CLOSED AND WOULD NOT OPEN AGAIN. NO FURTHER INFORMATION WAS AVAILABLE FROM THE SITE AS TO HOW THE DEVICE WAS REMOVED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103518 LIGASURE V SEALER/DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) S0EB041P

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK