BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE V SEALER/DIVIDER

    MDR report key: 5636892 · Received May 6, 2016

    Report

    Report Number
    3006451981-2016-00208
    Event Type
    Malfunction
    Date Received
    May 6, 2016
    Date of Event
    April 28, 2016
    Report Date
    April 28, 2016
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MAN
    Product Code
    GEI
    PMA / PMN Number
    K043273
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED LS1500 WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE LATCH WAS CLOSED. THE CUSTOMER REPORTED THAT THE HANDLE WAS CLOSED AND IT COULD NOT OPEN AGAIN. THE REPORTED CONDITION WAS CONFIRMED. FUNCTIONAL TESTING FOUND THAT IT WAS DIFFICULT TO UNLATCH THE HANDLE TO OPEN THE JAWS OF THE DEVICE. THIS CONDITION IS CONSISTENT WITH THE SKI IMPROPERLY ALIGNED IN THE INTERNAL A-TRACK DUE TO LATERAL FORCE PLACED ON THE LATCH OR LEAVING THE INSTRUMENT LATCHED FOR AN EXTENDED PERIOD OF TIME CAUSING THE SKI GUIDE TO BEND. THE LATCH WAS FORCED OPEN AND INSPECTION NOTED BLOOD BETWEEN THE JAWS INDICATING THE INSTRUMENT HAD BEEN USED ON A PATIENT. THE INVESTIGATION IDENTIFIED THE ROOT CAUSE OF THE REPORTED EVENT TO BE ATTRIBUTED TO USER MISHANDLING. THE IFU CAUTIONS THE USER, DO NOT LEAVE THE HANDLE LATCHED FOR AN EXTENDED PERIOD OF TIME WHEN THE DEVICE IS NOT IN USE.

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE #: (B)(4). DATE OF INITIAL REPORT: 05/062/016. THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER CONNECTING THE INSTRUMENT LS1500 TO A FORCE TRIAD, THE HANDLE WAS CLOSED AND IT COULD NOT OPEN AGAIN. THIS HAPPENED PRE-OPERATION; NOT USED IN THE PATIENT. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293905 LIGASURE V SEALER/DIVIDER LIGASURE VESSSEL SEALING SYSTEM GEI COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MAN LS1500 S5FB018X

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR