BEUDAMED
    FDA Adverse Event Other Summary report: N

    ECHELON FLEX

    MDR report key: 19350611 · Received May 20, 2024

    Report

    Report Number
    19350611
    Event Type
    Other
    Date Received
    May 20, 2024
    Date of Event
    January 11, 2024
    Report Date
    January 22, 2024
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    STAPLE LOADS STOPPED BEING ABLE TO BE LOADED, MAKING IT UN-OPERABLE. REPORTED TO MANUFACTURER AND RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147501 ECHELON FLEX STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC PSEE60A A9EF9M

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female