BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE

    MDR report key: 6170928 · Received December 13, 2016

    Report

    Report Number
    3004444684-2016-00004
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    November 8, 2016
    Report Date
    November 14, 2016
    Manufacturer
    MEDIGUS LTD
    Product Code
    ODE
    PMA / PMN Number
    K132151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MDR EXEMPTION E2013040. THIS MDR WAS ORIGINALLY SUBMITTED ON DECEMBER 9, 2016, BUT IT WAS NOT ACCEPTED BECAUSE IT WAS SUBMITTED AS AN XML FILE INSTEAD OF A ZIP FILE.

    Description of Event or Problem · 0

    IT WAS BROUGHT TO OUR ATTENTION THAT ON (B)(6) 2016, DURING THE PREPARATION STAGE FOR A MUSE PROCEDURE AND AFTER THE INSERTION OF THE OVERTUBE, THE PHYSICIAN NOTICED A POSSIBLE LACERATION OF THE ESOPHAGEAL WALL. THE PHYSICIAN DECIDED TO PLACE A STENT. THE MUSE PROCEDURE WAS CANCELLED AND THE ENDOSTAPLER WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822163 MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE ENDOSTAPLER ODE MEDIGUS LTD SRS05

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention