BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILS 29MM, CURVED

    MDR report key: 3143362 · Received June 3, 2013

    Report

    Report Number
    3005075853-2013-02762
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 10, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT AND CUT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICE ACHIEVED A FULL FIRING STROKE. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY. IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOID PROCEDURE ON THE COLON DESCENDENS, DEVICE DID NOT STAPLE BUT CUT. THERE WAS A LEAKAGE IN THE ANASTOMOSIS; AT THE PART OF THE LEAKAGE THERE WERE NO STAPLES VISIBLE. ANASTOMOSIS WAS ACHIEVED SUCCESSFULLY WITH A COVIDIEN STAPLER IN A SECOND ATTEMPT. THERE WERE NO NEGATIVE CONSEQUENCES FOR THE PATIENT; PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244542 ILS 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK 05YJ9W

    Patients

    Seq Age Sex Outcome Treatment
    1