BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG

    MDR report key: 1962099 · Received January 17, 2011

    Report

    Report Number
    3005075853-2011-00217
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 13, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). YOKE TEETH. THE ANALYSIS RESULTS FOUND THAT AN ETS45 DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITHOUT RELOAD PRESENT. THE CLAMPING WAS NOTED TO BE DAMAGED. NO FUNCTIONAL TEST WAS PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE YOKE TEETH WERE FOUND BROKEN. ALTHOUGH NO CONCLUSION COULD BE REACHED AS TO HOW THE YOKE TEETH BECAME BROKEN, THIS DAMAGE CAN OCCUR WHEN EXCESSIVE FORCE IS APPLIED TO THE CLOSING TRIGGER WHEN THE JAWS ARE CLAMPED ON TISSUE THICKER THAN INDICATED. IN ADDITION, IT SHOULD BE NOTED THAT AT LEAST A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; (B)(4). A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN NEPHRECTOMY PROCEDURE, THE DEVICE WAS DIFFICULT TO CLOSE THEN FIRED USING A WHITE LOAD, THERE WAS AN UNUSUAL SOUND. THE DEVICE FIRED OKAY AND WAS ABLE TO BE REMOVED HOWEVER THE FIRING TRIGGER DID NOT GOT BACK TO NORMAL POSITION AND THE JAWS DID NOT OPEN FULLY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX ARTICNG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1