BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG

    MDR report key: 2063645 · Received April 19, 2011

    Report

    Report Number
    3005075853-2011-01577
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 1, 2011
    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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). YOKE TEETH. THE ANALYSIS RESULTS FOUND THAT AN ATS45 DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED FULLY LOADED WITH STAPLES AND WITH NO DAMAGE TO THE SPRING CARTRIDGE LOCKOUT. THE CLAMPING AND THE FIRING MECHANISM WERE NOTED TO BE DAMAGED. NO FUNCTIONAL TEST WAS PERFORMED DUE TO THE CONDITION OF THE DEVICE, HOWEVER THE RETURNED RELOAD WAS LOADED INTO A TEST DEVICE AND IT FIRED, CUT AND FORMAL ALL THE STAPLES AS INTENDED. 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; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4). THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HAND ASSISTED NEPHRECTOMY PROCEDURE, THE DEVICE WAS PLACED TO STAPLE ACROSS A VASCULAR STRUCTURE. UPON COMPLETION OF THE FIRING, THEY COULD NOT GET THE JAWS OFF THE VESSEL. THEY HAD TO DISSECT THE TISSUE AROUND THE DEVICE TO GET IT OFF WHERE THE TISSUE HAD BEEN CUT THROUGH. THE AREA WAS SUTURED CLOSED. THERE WAS NO IMPACT TO THE PATIENT. THE DEVICE IS CURRENTLY WITH RISK MANAGEMENT TO BE RETURNED AT A LATER DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1