BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUSE - MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER

    MDR report key: 4195789 · Received August 28, 2014

    Report

    Report Number
    3004444684-2014-00001
    Event Type
    Injury
    Date Received
    August 28, 2014
    Date of Event
    July 30, 2014
    Report Date
    August 26, 2014
    Manufacturer
    MEDIGUS, LTD.
    Product Code
    ODE
    PMA / PMN Number
    K132151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE PERFORMED AS INTENDED. NO MALFUNCTION OR DEFECT OF DEVICE NOTED. MEDIGUS LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF THE IMPORTER, (B)(4)).

    Description of Event or Problem · 1

    DURING THE PROCEDURE, A SUPERFICIAL LACERATION WAS VISUALIZED ON THE MUCOSA OF THE MID-ESOPHAGUS. ENDOSCOPIC CLIPS WERE PLACED OVER THE LACERATION. PLEURAL EFFUSION AND FREE AIR IN THE MEDIASTINUM (PNEUMOMEDIASTINUM) NOTED, BUT RESOLVED SPONTANEOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524607 MUSE - MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER ENDOSTAPLER ODE MEDIGUS, LTD. SRS05 22094

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention