BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUSE - MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER

    MDR report key: 4510213 · Received February 4, 2015

    Report

    Report Number
    3004444684-2015-00001
    Event Type
    Injury
    Date Received
    February 4, 2015
    Date of Event
    January 14, 2015
    Report Date
    February 2, 2015
    Manufacturer
    MEDIGUS, LTD.
    Product Code
    ODE
    PMA / PMN Number
    K132151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INCIDENT OCCURRED IN (B)(6). DEVICE PERFORMED AS INTENDED. NO MALFUNCTION OR DEFECT OF DEVICE NOTED AT TIME OF PROCEDURE. PREVIOUS ESOPHAGOGASTRIC PROCEDURES HAVE BEEN EXCLUDED FROM ALL CLINICAL STUDIES AND ARE CONTRAINDICATED IN THE DEVICE IFU. MEDIGUS LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF THE IMPORTER, (B)(4).

    Description of Event or Problem · 1

    IMP REF# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81346 MUSE - MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER ENDOSTAPLER ODE MEDIGUS, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention