BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA ULTRA UNIVERSAL STAPLER

    MDR report key: 4739448 · Received April 30, 2015

    Report

    Report Number
    2647580-2015-00305
    Event Type
    Injury
    Date Received
    April 30, 2015
    Date of Event
    April 22, 2015
    Report Date
    April 28, 2015
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE ENDO GIA* ULTRA UNIVERSAL 12MM SINGLE USE INSTRUMENT (R/C: EGIAUSTND), LOT P4K0858X, AND ONE ENDO GIA* UNIVERSAL ROTICULATOR* 30-3.5 SINGLE USE LOADING UNIT (R/C: 030452), LOT N4K1464KX, BOTH OPENED BY THE CUSTOMER. THIS EVALUATION WAS BASED ON A MEDICAL AND TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE CUSTOMER, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, ENGINEERING REVIEW OF THE PRODUCT, AND AN EVALUATION OF THE RETURNED DEVICES. VISUAL INSPECTION OF THE INSTRUMENT FOUND NO ABNORMALITIES. THE INSTRUMENT FIRING KNOBS WERE RETRACTED, AND THE ARTICULATION LEVER WAS IN THE NEUTRAL POSITION. VISUAL INSPECTION OF THE CARTRIDGE SURFACE OF THE LOADING UNIT NOTED THAT IT WAS RECEIVED FULLY FIRED. TWO PROPERLY FORMED STAPLES WERE OBSERVED ON THE DISTAL CARTRIDGE SURFACE WITH ONE STAPLE ADHERED TO THE CARTRIDGE SURFACE AND ANOTHER WITHIN THE OPENING OF THE KNIFE SLOT BETWEEN THE CUT LINE AND 1CM CUT LINE (PHOTOS 2 AND 4). ENGINEERING EVALUATION OF THE LOADING UNIT CONFIRMED THE PRESENCE OF TWO PROPERLY FORMED STAPLES ON THE DISTAL CARTRIDGE SURFACE AND CONFIRMED STAPLE STRIKES WITHIN THE ANVIL POCKETS INDICATING STAPLES WERE DEPLOYED FROM THE CARTRIDGE AND MADE CONTACT WITH THE ANVIL POCKETS FOR STAPLE FORMATION (PHOTOS 7, 8, AND 9). ADDITIONALLY, ALL STAPLE PUSHERS WERE OBSERVED TO BE ADVANCED, AND THE SLED WAS FULLY ADVANCED INSIDE THE CARTRIDGE ASSEMBLY INDICATING A COMPLETE FIRING (PHOTOS 2, 4, AND 6). FUNCTIONALLY, THE INSTRUMENT WAS LOADED WITH A PMV REPRESENTATIVE STRAIGHT (R/C: 030414) AND A ROTICULATOR* (R/C: 030459) LOADING UNITS. THE INSTRUMENT SUCCESSFULLY, CLAMPED, CYCLED FULLY, OPENED AND UNLOADED REPEATEDLY WITHOUT DIFFICULTY. THE LOADING UNITS WERE LOADED INTO THE SUBJECT INSTRUMENT FOR FUNCTIONAL TESTING. THE LOADING UNITS WERE CYCLED WITHOUT HESITATION OR BINDING. FUNCTIONAL TESTING CONFIRMED THE SAFETY INTERLOCK FEATURE SUCCESSFULLY PREVENTED THE LOADING UNITS FROM CYCLING AGAIN. A REVIEW OF THE DEVICE HISTORY RECORDS FOR LOT P4K0858X AND N4K1464KX INDICATES EACH DEVICE LOT NUMBER WAS RELEASED MEETING ALL MEDTRONIC QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY AMENDED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 04/30/2015.

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC BOWEL RESECTION ON (B)(6) 2015. ACCORDING TO THE REPORTER: THE STAPLER WAS USED TO STAPLE ACROSS A PORTION OF THE BOWEL. THE STAPLER PARTIALLY FIRED HALF WAY ACROSS. THE PROCEDURE HAD TO BE CONVERTED TO AN OPEN LAPAROTOMY AND WAS COMPLETED USING SUTURE. NO REINFORCEMENT MATERIAL WAS USED. THERE WAS NO UNANTICIPATED TISSUE LOSS OR TISSUE DAMAGE. THERE WAS NO BLEEDING IN EXCESS OF 500CC. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE DEVICE PROBLEM. THE PATIENT DID HAVE AN EXTENDED HOSPITAL STAY AS THE PROCEDURE WAS CONVERTED FROM A LAPAROSCOPIC PROCEDURE TO AN OPEN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283311 EGIA ULTRA UNIVERSAL STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO INC EGIAUSTND P4K0858X

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R