BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUSE - MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER

    MDR report key: 5272355 · Received December 7, 2015

    Report

    Report Number
    3004444684-2015-00002
    Event Type
    Injury
    Date Received
    December 7, 2015
    Date of Event
    November 9, 2015
    Report Date
    November 9, 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

    EVENT OCCURRED IN (B)(6). DEVICE PERFORMED AS INTENDED; NO MALFUNCTION OR DEFECT OF DEVICE NOTED AT TIME OF PROCEDURE. (B)(4)

    Description of Event or Problem · 1

    AFTER THE FIRST STAPLING WAS COMPLETED DURING AN ENDOSCOPIC FUNDOPLICATION PROCEDURE WITH THE MUSE DEVICE, AN INSPECTION WAS CONDUCTED WITH A STANDARD GASTROSCOPE. A SMALL GASTRIC PERFORATION WAS NOTED. THE PERFORATION WAS CLOSED ENDOSCOPICALLY. PER THE ATTENDING PHYSICIAN, THE SUBJECT SUFFERED NO ADDITIONAL ILL EFFECTS AND RECOVERED UNEVENTFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800238 MUSE - MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER ENDOSTAPLER ODE MEDIGUS, LTD. SRS05

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention