BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUSE-MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM

    MDR report key: 5489220 · Received March 9, 2016

    Report

    Report Number
    3004444684-2016-00001
    Event Type
    Injury
    Date Received
    March 9, 2016
    Date of Event
    January 12, 2016
    Report Date
    February 19, 2016
    Manufacturer
    MEDIGUS LTD.
    Product Code
    ODE
    PMA / PMN Number
    K132151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE PERFORMED AS INTENDED. NO MALFUNCTION OR DETECT OF DEVICE NOTED. (B)(4). ANATOMY RELATED ISSUE, NOT DEVICE. MDR EXEMPTION E2013040.

    Description of Event or Problem · 0

    AT THE TIME OF DISCHARGE, THE PATIENT NOTICED SHE COULD NOT PROPERLY CLOSE HER JAW AND LATER COMPLAINED OF JAW PAIN. CONSERVATIVE MANAGEMENT RECOMMENDED. JAW OCCLUSION/PAIN IMPROVED, BUT WAS NOT COMPLETELY RESOLVED UPON 30-DAY TELEPHONE FOLLOW-UP. SUBJECT WAS FOUND NOT TO BE COMPLIANT WITH HER THERAPEUTIC PROGRAM. MANUFACTURER NOTIFIED DUE TO PERSISTENCE OF JAW ISSUE. PHYSICIAN ATTRIBUTED EVENT TO THE PATIENT'S ANATOMY (ESOPHAGUS/UPPER GI TRACT WAS A TIGHT FIT AROUND DEVICE). PATIENT CONTINUES ON CONSERVATIVE MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144800 MUSE-MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM ENDOSTAPLER, PRODUCT CODE: ODE ODE MEDIGUS LTD. SRS05 23400

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Disability