BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUSE - MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER

    MDR report key: 5634585 · Received May 5, 2016

    Report

    Report Number
    3004444684-2016-00002
    Event Type
    Injury
    Date Received
    May 5, 2016
    Date of Event
    April 11, 2016
    Report Date
    April 11, 2016
    Manufacturer
    MEDIGUS, LTD.
    Product Code
    ODE
    PMA / PMN Number
    K132151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE PERFORMED AS INTENDED. NO MALFUNCTION OR DEFECT OF DEVICE NOTED. (B)(4). MANUFACTURER: MEDIGUS LTD. (B)(4). MDR EXEMPTION E2013040.

    Description of Event or Problem · 0

    ESOPHAGEAL TEAR OBSERVED DURING INSERTION OF DEVICE. ESOPHAGEAL STENT PLACED. AFTER ESOPHAGEAL LEAK RULED OUT, PATIENT OBSERVED IN ICU FOR 24 HOURS AND PATIENT DISCHARGED NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290903 MUSE - MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER ENDOSTAPLER ODE MEDIGUS, LTD. SRS05 23400

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention