BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILS 29MM, CURVED

    MDR report key: 9443604 · Received December 10, 2019

    Report

    Report Number
    3005075853-2019-24128
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    October 17, 2019
    Report Date
    November 14, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036003465
    PMA / PMN Number
    K983536
    Removal / Correction Number
    Z-1269-2019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH #: R5AF26. DEVICE EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE CDH29A DEVICE ARRIVED WITH NO APPARENT DAMAGE. THE BREAKAWAY WASHER WAS PRESENT AND UNCUT, THE DEVICE WAS FULLY LOADED WITH STAPLES, INDICATING THAT THE DEVICE HAD NOT BEING FIRED. DURING DEVICE TESTING THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH THE RETURNED WASHER; THE DEVICE WAS FIRED OVER TEST SKIN; THE WASHER WAS NOT CUT, AND MALFORMED STAPLES WERE OBSERVED. DURING FIRING OF THE DEVICE, IT WAS NOTED THAT THE ADJUSTMENT KNOB ROTATED ROUGHLY ½ TURN FROM THE STARTING POSITION. NO CONCLUSION COULD BE REACHED AS TO WHAT CAUSED THE MALFORMED STAPLES. IT SHOULD BE NOTED THAT 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ADDITIONAL ANALYSIS CONFIRMED THE DEVICE TO HAVE AN UNCUT WASHER.¿ DEVICE BATCH INFORMATION WAS REVIEWED, AND IT WAS CONFIRMED TO BE MANUFACTURED WITHIN THE BOUNDING OF THE FIELD ACTION.¿ THE DEVICE WAS RELOADED WITH STAPLES AND ADDITIONAL TISSUE TESTING WAS PERFORMED.¿ THE DEVICE CUT THE WASHER AND HAD ACCEPTABLE STAPLE FORMATION WHEN FIRED INTO INDICATED TISSUE THICKNESS. THE DEVICE PERFORMED AS INTENDED DURING TISSUE TESTING. IN THE ADDITIONAL TESTING, THEY PERFORMED A FIRING OF THE DEVICE ON THE FORCE TO FIRE (FTF) MACHINE AND RECORDED A VARIABLE MEASUREMENT FOR BACK-DRIVE. THE DEVICE WAS RELOADED WITH STAPLES AND FIRED INTO TEST SKIN AT HIGH B. THE FIRING ON THE FTF MACHINE DEMONSTRATED AN UNCUT WASHER, AT END OF CYCLE (WASHER BREAK DID NOT OCCUR), A STAPLE LINE THAT WOULD BE CLASSIFIED AS A DEFECT. BASED ON THE ANALYSIS PERFORMED THE MOST LIKELY CAUSE OF THE MALFORMED STAPLE DEFECT IS BACK-DRIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE ENDOSCOPIC SCIATIC HEMICOLECTOMY SURGERY, COULD NOT FIRE. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243382 ILS 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. CDH29A R4142U 10705036003465

    Patients

    Seq Age Sex Outcome Treatment
    1