BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 3170997 · Received June 14, 2013

    Report

    Report Number
    3005075853-2013-03043
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 31, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: (B)(4) 2013. INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT DEVICE (A) WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE LOADED ON THE DEVICE. 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. EVENT COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED DURING THE FUNCTIONAL TESTING. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE ANALYSIS FOUND THAT DEVICE (B) WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH AN ECR60B CARTRIDGE LOADED ON THE DEVICE; THE RELOAD WAS NOTED TO BE RIGHT SIDE FULLY FIRED, LEFT SIDE OUTER ROW FULLY FIRED AND THE TWO LEFT INNER ROWS PARTIALLY FIRED. NO OBVIOUS DAMAGE TO THE CARTRIDGE DECK WAS NOTED, WHICH SUGGESTS THE CARTRIDGE, MAY NOT HAVE BEEN FIRED OVER A HARD OBJECT. UPON EVALUATION OF THE RELOAD, THE CARTRIDGE BODY, ONE PIECE SLED AND SOME DRIVERS WERE NOTED TO BE DAMAGED. 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 CUT WAS NOTED TO BE JAGGED DUE TO A DAMAGED KNIFE. 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. BATCH # K59V06 (MFG DATE: 3/4/2013 EXP DATE: 2/4/2018).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, THE DEVICE WAS LOADED WITH A BLACK CARTRIDGE, POSITIONED ON TISSUE AND ATTEMPTED TO FIRE. THEY COULD HEAR THE BATTERY ENGAGE BUT IT DID NOT ADVANCE AT ALL AND THEN LOCKED OUT. THEY TOOK OUT THE CARTRIDGE AND LOADED A NEW ONE AND THE SAME EVENT OCCURRED. A NEW DEVICE WAS PULLED AND LOADED WITH A NEW CARTRIDGE AND IT WORKED FINE. ON THE THIRD FIRING WITH A BLUE CARTRIDGE, THE STAPLE LINE WAS MALFORMED. THE SURGEON NOTICED AFTER FIRING THE DEVICE THAT ONE SIDE OF THE DRIVERS WAS NOT PUSHED UP. IT HAD NOT DEPLOYED ONE SIDE OF THE STAPLES. A NEW CARTRIDGE WAS LOADED, FIRED AND IT WORKED SUCCESSFULLY. IN THE SAME PROCEDURE TOWARD THE END AFTER THE NSEAL DEVICE HAS BEEN ACTIVATED SEVERAL TIMES, THE JAWS WOULD NOT OPEN TO FULL APERTURE. THEY WERE NOT ABLE TO PUSH THE JAW OPEN TO FULL APERTURE. THE PROCEDURE WAS COMPLETED WITHOUT IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270531 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60T, ECR60B