BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 3111663 · Received May 14, 2013

    Report

    Report Number
    3005075853-2013-02315
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 22, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION REQUESTED AND RECEIVED: THE EVENT OCCURRED ON THE SECOND FIRING. ATS45 WAS USED. TR45W WAS USED ON THE FIRST AND THIRD FIRINGS. NO BUTTRESSING MATERIALS WERE USED. THE INSTRUMENT WASN¿T FIRED ACROSS AN EXISTING STAPLE LINE OR CLIP. THEY DIDN¿T HEAR THE CLICK OF THE CLOSING HANDLE BEFORE FIRING. NO UNUSUAL SOUNDS WERE HEARD UPON FIRING. UNKNOWN WHETHER THE TRIGGERS AND BUTTONS RETURNED TO NORMAL POSITION. NO DIFFICULTY REMOVING THE INSTRUMENT FROM THE TISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS SHOWED THAT A TR45W CARTRIDGE RELOAD WAS RECEIVED FOR ANALYSIS; IT WAS NOTED TO BE PARTIALLY FIRED 1/3. FURTHERMORE, THE CARTRIDGE METAL PAN WAS NOTED TO HAVE SCRATCHES ON THE BOTTOM. THE SCRATCHES WERE STRAIGHT AND RUNNING PARALLEL TO THE BOTTOM WITH RESPECT TO THE CARTRIDGE AND PARALLEL IN RESPECT TO THE DEVICE CHANNEL (METAL LOWER JAW COMPONENT THAT HOLDS THE CARTRIDGE IN PLACE). THE SCRATCHES ON THE CARTRIDGE METAL PAN AND THE INFORMATION PROVIDED IN THE EVENT DESCRIPTION ARE CONSISTENT WITH AN IMPROPER LOADING OF THE CARTRIDGE INTO THE DEVICE. WHEN THE CARTRIDGE IS NOT LOADED COMPLETELY THAT IS THE CARTRIDGE STOPS ARE NOT IN THE CARTRIDGE RELOAD ALIGNMENT SLOT, AT FIRING THE RELOAD WILL EJECT FORWARD AND SOME STAPLES WILL DEPLOY (FIRE OUT). PER INSTRUCTIONS FOR USE INSERT THE NEW RELOAD BY SLIDING IT AGAINST THE BOTTOM OF THE CARTRIDGE JAW UNTIL IT STOPS IN THE RELOAD ALIGNMENT SLOT. SNAP THE RELOAD SECURELY IN PLACE. THE RETURNED RELOAD WAS LOADED INTO A TEST DEVICE USING THE STEPS ON THE INSTRUCTIONS FOR USE AND THE RELOAD WAS LOADED COMPLETELY WITHOUT ANY DIFFICULTY NOTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEPATIC LOBECTOMY PROCEDURE, THE DEVICE WAS FIRED ONCE AND WORKED PROPERLY. THE DEVICE WAS RELOADED WITH A VASCULAR RELOAD. THE RESIDENT NOTED THAT HE DIDN'T HEAR A CLICK WHEN CLOSING THE INSTRUMENT ON THE PORTAL VEIN. THE DEVICE WAS FIRED AND THE CARTRIDGE PUSHED OUT OF THE JAWS. STAPLES WERE FORMED ABOUT A THIRD OF THE WAY, BUT THERE WAS NO CUT. THEY USED TRADITIONAL CLAMP, CUT, AND TIE TO TRANSECTION THE PORTAL VEIN. THERE WAS NO BLOOD LOSS AS A RESULT. THE STAPLER WAS USED WITH A NEW CARTRIDGE ON ANOTHER ARTERY WITHOUT INCIDENT. THE CASE WAS LENGTHENED SLIGHTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211761 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 ATS45