BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 3150156 · Received June 6, 2013

    Report

    Report Number
    3005075853-2013-02840
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE RELOAD PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE RELOAD AND IT ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. HOWEVER, THE KNIFE WAS NOTED NICKED. ONE POSSIBLE CAUSE FOR THIS TYPE OF DAMAGE TO THE KNIFE IS WHEN THE DEVICE IS FIRED OVER AN ALREADY EXISTING STAPLE LINE, HARD OBJECT OR THICKER TISSUE THAN INDICATED. REPEATEDLY FIRING ACROSS EXISTING STAPLE LINES CAN ALSO REDUCE THE ABILITY TO CUT CLEANLY. TO MITIGATE THE POTENTIAL FOR STAPLES GETTING INTO THE CARTRIDGE AND INTERFERING WITH THE KNIFE PATH DURING DEVICE FIRING, PRIOR TO RELOADING THE DEVICE, RINSE THE ANVIL AND CARTRIDGE JAW IN STERILE SOLUTION AND THEN WIPE THE ANVIL AND CARTRIDGE JAW TO CLEAN ANY FORMED BUT UNUSED STAPLES FROM THE DEVICE. ADDITIONALLY, PROPER CARE SHOULD BE TAKEN WHEN PLACING THE DEVICE ON THE TISSUE TO BE STAPLED, TO ENSURE THAT NO HARD OBSTRUCTION SUCH AS A CLIP IS INCLUDED WITH THE TISSUE INSIDE THE JAWS. IN ADDITION, TWO ECR60D RELOADS WERE RECEIVED INSIDE A SEPARATED BAG; THEY WERE NOTED FULLY FIRED. THE RELOADS WERE DISASSEMBLED AND NO ANOMALIES WERE NOTED. PLEASE NOTE AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION REQUESTED AND RECEIVED: ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? STOMACH. WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? UNKNOWN. ON WHICH FIRING(S) DID THIS EVENT OCCUR? 7TH. WHAT COLOR CARTRIDGE WAS BEING USED? GOLD. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? BLACK, GREEN, AND GOLD. WAS BUTTRESSING MATERIAL UTILIZED? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? ALL FIRINGS WERE THROUGH STAPLE LINES. WERE ANY UNEXPECTED NOISES HEARD? NO. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? YES. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE PROCEDURE, THE DEVICE WAS FIRED WITH TWO BLACK LOADS, THEN FOUR GREEN, THEN GOLD AND GOLD AGAIN. ON THE 7TH FIRING WITH THE GOLD RELOAD THE STAPLES WERE MALFORMED AND THE SURGEON SAID THE DEVICE MISFIRED. THE DEVICE CUT HALF THE DISTANCE AND STAPLED THE FULL LENGTH. THE TISSUE SEEMED TO BE PUSHED AND CRIMPED. THE SAME DEVICE WITH NEW RELOADS WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251009 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1