BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 LONG

    MDR report key: 1860690 · Received October 7, 2010

    Report

    Report Number
    3005075853-2010-05769
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    June 22, 2010
    Report Date
    July 7, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ARTICULATION LINK. THE ANALYSIS FOUND THAT ONE LONG60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE RELOAD PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH A TEST CARTRIDGE RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. UPON FURTHER INSPECTION THE JOINT COVER WAS NOTED TO BE TORN; THERE IS NO EVIDENCE THAT THERE IS ANY PORTION OF THE JOINT COVER MISSING. IN ADDITION, THE ARTICULATION LINK WAS FOUND BROKEN. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE ARTICULATION LINK BECAME DAMAGED, IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS. 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 GASTRIC BYPASS PROCEDURE, THE DEVICE MISFIRED STAPLES. NO OTHER DETAILS WERE PROVIDED. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 LONG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4RR5X

    Patients

    Seq Age Sex Outcome Treatment
    1