BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 3830362 · Received May 23, 2014

    Report

    Report Number
    3005075853-2014-03528
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 1, 2014
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE PLE60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH TWO ECR60G CARTRIDGE RELOADS PRESENT AND SIX ECR60D CARTRIDGE RELOADS PRESENT. THE RETURNED RELOADS (C, D, E, F, G, H, I, J) WERE RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE RELOAD AND 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. 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 EVENT COULD NOT BE CONFIRMED AS NO INCOMPLETE STAPLE LINE WAS NOTED DURING FUNCTIONAL TESTING. 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 ROBOTIC SLEEVE GASTRECTOMY PROCEDURE, THE LAST FIRING OF THE STOMACH WITH GOLD LOAD (ECR60D) THE STAPLES FIRED COMPLETELY ON THE SPECIMEN SIDE AND ON THE PATIENT SIDE THERE WAS A GAP OF NO STAPLES AT THE END OF THE STOMACH. THE SURGEON SEWED THE HOLE CLOSED TO COMPLETE THE CASE. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307804 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOADS-ECR60G ECR60D