BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EGIA 30 ARTICULATING MED/THICK SULU

    MDR report key: 5249738 · Received November 25, 2015

    Report

    Report Number
    1219930-2015-01024
    Event Type
    Malfunction
    Date Received
    November 25, 2015
    Date of Event
    March 19, 2015
    Report Date
    April 6, 2015
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). POST MARKET VIGILANCE (PMV) CONDUCTED AN EVALUATION OF ONE ENDO GIA¿ ULTRA UNIVERSAL 12MM SINGLE USE INSTRUMENT AND ONE ENDO GIA¿ 30MM ARTICULATING MEDIUM/THICK RELOAD BOTH OPENED BY THE ACCOUNT. VISUAL INSPECTION OF THE CARTRIDGE REVEALED THAT THE RELOAD CARTRIDGE HAD SMALL WHITE STAINS PRESENT ON ITS SURFACE WHICH APPEARED TO BE DRIED TEFLON. TEFLON LUBRICANT IS USED DURING THE ASSEMBLY PROCESS TO HELP ALLEVIATE ANY BINDING CONDITIONS. IN A SUBSEQUENT ASSEMBLY STEP, THE CARTRIDGE IS WIPED CLEAN OF EXCESS TEFLON. THE AMOUNT OF TEFLON MATERIAL OBSERVED DID NOT APPEAR TO BE EXCESSIVE. PLEASE NOTE HOWEVER, THAT TEFLON LUBRICANT HAS BEEN SUBJECTED TO BIOLOGICAL TESTING AND CONFIRMED TO BE ACCEPTABLE FOR PATIENT CONTACT. VISUAL INSPECTION OF THE INSTRUMENT NOTED THAT THE ARTICULATION LEVER HAD DISENGAGED FROM THE ROTATION COLLAR. INSUFFICIENT MATERIAL TRANSFER WAS OBSERVED ON THE LEVER, SUGGESTING IMPROPER ASSEMBLY OF THE ARTICULATION LEVER. FUNCTIONALLY, THE INSTRUMENT WAS LOADED WITH POST MARKET VIGILANCE REPRESENTATIVE STRAIGHT AND ROTICULATOR¿ LOADING UNITS. THE INSTRUMENT SUCCESSFULLY, CLAMPED, CYCLED FULLY, OPENED AND UNLOADED REPEATEDLY WITHOUT DIFFICULTY. THE ARTICULATION FUNCTION COULD NOT BE TESTED DUE TO THE DISENGAGED LEVER. (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING A ROBOTIC ASSISTED PNEUMONECTOMY, THE SCRUB TECH WAS LOADING THE RELOAD ONTO THE HANDLE, AND NOTICED A WHITE CHALKY RESIDUE ON THE LOADING TIP OF THE RELOAD. THE SURGEON WAS CONCERNED ABOUT STERILITY AND WOULD NOT USE THE RELOAD. ANOTHER RELOAD FROM ANOTHER LOT WAS USED INSTEAD. CURRENT PATIENT STATUS: STABLE AND RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782132 EGIA 30 ARTICULATING MED/THICK SULU STAPLE, IMPLANTABLE GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON EGIA30AMT N4A0150GX

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR