BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EGIA 60 ARTICULATING MED/THICK SULU

    MDR report key: 5697555 · Received June 3, 2016

    Report

    Report Number
    1219930-2016-00588
    Event Type
    Malfunction
    Date Received
    June 3, 2016
    Date of Event
    May 12, 2016
    Report Date
    May 12, 2016
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE IDRIVE ULTRA POWERED HANDLE 1, ONE ENDO GIA ADAPTER XL, AND TWO ENDO GIA* 60 MM ARTICULATING MEDIUM/THICK RELOADS OPENED BY THE ACCOUNT. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, AN ENGINEERING EVALUATION OF THE DEVICES, AND AN EVALUATION OF THE RETURNED DEVICES. NO VISUAL ABNORMALITIES WERE NOTED FOR THE HANDLE OR ADAPTER. THE JAWS OF THE RELOADS WERE CLAMPED. THIS INDICATED THAT THE JAWS DID NOT OPEN WHEN THE INSTRUMENT OPEN BUTTONS WERE PRESSED. DEVICES WERE DISASSEMBLED AND LOCK RINGS WERE REMOVED FROM THE DEVICES. THE LOCKING TABS ON THE LOCK RINGS EXHIBITED EXTENSIVE DAMAGE. REPLICATION OF THE CLAMPED RELOAD CONDITION MAY OCCUR BY REMOVING THE SHIPPING WEDGE AND LOADING THE RELOAD AT AN EXTREME ANGLE WITH EXCESSIVE FORCE. LOADING UNDER THESE CONDITIONS CAN FORCE THE KNIFE BAR ASSEMBLY THROUGH THE RETAINING FEATURE IN THE LOCK RING. AN IMPROPER LOAD ALLOWS THE KNIFE TO ADVANCE BUT PREVENTS RETRACTION FOR UNCLAMPING. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THEY COULDN'T GET THE RELOAD TO OPEN. ALL OF THE STATUS LIGHTS WERE GREEN. IT MADE THE SOUND AS IF IT WOULD OPEN AND DIDN'T. EVENTUALLY, IT CYCLED AND THE LIGHT CHANGED TO A BLINKING RELOAD LIGHT AND BLUE SIDE LIGHTS. THE RELOAD STILL DID NOT OPEN. THE TECH PULLED DOWN ON THE UNLOAD BUTTON AND WAS ABLE TO UNLOAD THE RELOAD. THE HANDLE CYCLED AGAIN AND THERE WERE TWO GREEN STATUS LIGHT UNDER THE HANDLE AND ADAPTER ICONS. THE TECH THEN TOOK A NEW RELOAD AND LOADED IT AND FIRED IT ON A PIECE OF PAPER TO TEST IT TO SEE IF IT WOULD WORK PROPERLY AND IT DID. THEY THEN PROCEEDED TO USE THE HANDLE ON THE NEXT TWO TAN FIRINGS AND IT WORKED APPROPRIATELY. ON THE LAST FIRING OF THE 45 PURPLE IT LOADED AND CYCLED CORRECTLY. THE SURGEON APPROXIMATED IT ON TISSUE AND WHEN TO PUT IT IN FIRE MODE AND IT MADE A SOUND AS IF IT PARTIALLY FIRED AND THEN THE BLUE STATUS LIGHTS WERE ON. THEY FINISHED THAT LAST FIRE WITH A MANUAL HANDLE. THIS ADDED APPROXIMATELY 45 MINUTES TO HIS CASE. THERE WAS NO EXTRA BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351181 EGIA 60 ARTICULATING MED/THICK SULU STAPLE, IMPLANTABLE GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON EGIA60AMT N6A0435KX

    Patients

    Seq Age Sex Outcome Treatment
    1