BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICING LNR CUTR 45MM

    MDR report key: 1231203 · Received November 10, 2008

    Report

    Report Number
    3005075853-2008-02905
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Report Date
    October 10, 2008
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DAMAGED ARTICULATION GEAR TEETH. EVALUATION SUMMARY: THE ANALYSIS SHOWED THAT THE DEVICE WAS RECEIVED WITH THE ARTICULATION MECHANISM DAMAGED. THE DEVICE WAS RECEIVED WITH TWO RELOADS PRESENT; THE RELOADS WERE RECEIVED FULLY FIRED AND WITH NO DAMAGE TO THE SPRING RELOAD LOCKOUT. THE RETURNED DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD ON THE THREE ARTICULATED POSITIONS; WHEN FIRED TO THE LEFT AND CENTER, THE STAPLE FORMATION WAS CONFORMING. HOWEVER, WHEN FIRED IN THE RIGHT POSITION, THE STAPLES WERE MALFORMED DUE TO THE DAMAGED ARTICULATION MECHANISM. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE ARTICULATION GEAR TEETH WERE FOUND BROKEN. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT FGQA. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, THE APPROPRIATE ENGINEERING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT. AN INVESTIGATION HAS BEEN INITIATED TO DETERMINE THE CAUSE OF THIS ISSUE. 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 A COLECTOMY, THE DEVICE LOCKED OUT. IT WOULD NOT FIRE AT ALL. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX ARTICING LNR CUTR 45MM GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1