BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60 MM

    MDR report key: 4123356 · Received September 26, 2014

    Report

    Report Number
    3005075853-2014-06700
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 19, 2014
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND. DEVICE MET RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN SIGMOIDECTOMY, A CARTRIDGE COULD NOT BE LOADED INTO THE DEVICE AT THE 2ND FIRING. THE CARTRIDGE PAN OF A PREVIOUS CARTRIDGE WAS LEFT IN THE JAW. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602872 ECHELON*FLEX60 ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60 MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK L4EH8C

    Patients

    Seq Age Sex Outcome Treatment
    1