BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURESTRAP

    MDR report key: 2250838 · Received September 2, 2011

    Report

    Report Number
    2250838
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 15, 2011
    Report Date
    September 2, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ETHICON SECURE STRAP 5MM ABSORBABLE STRAP FIXATION DEVICE WOULD NOT FIRE INTO THE TISSUE AS EXPECTED. NO HARM TO THE PATIENT. INSTRUMENT REPLACED WITH ANOTHER TO FINISH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURESTRAP FIXATION DEVICE GDW ETHICON ENDO-SURGERY, INC. STRAP25 H206STRAP252M

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR