BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE

    MDR report key: 6684898 · Received July 3, 2017

    Report

    Report Number
    3004444684-2017-00002
    Event Type
    Injury
    Date Received
    July 3, 2017
    Date of Event
    June 7, 2017
    Report Date
    June 7, 2017
    Manufacturer
    MEDIGUS LTD
    Product Code
    ODE
    UDI-DI
    07290014036062
    PMA / PMN Number
    K132151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) WAS USED AS A PATIENT CODE BECAUSE THERE WERE NO CODES THAT FIT THE DIAGNOSIS OF PNEUMOPERITONEUM.

    Description of Event or Problem · 1

    AFTER MUSE SURGERY ON (B)(6) 2017, THE PATIENT BEGAN TO EXPERIENCE DISCOMFORT. TEST RESULTS INDICATED THAT HE HAD DEVELOPED A PNEUMOPERITONEUM. HE WAS GIVEN GASTROINTESTINAL DECOMPRESSION TREATMENT, REHYDRATION AND MEDICATIONS TO REDUCE PAIN AND PREVENT INFECTION. THE PATIENT'S HOSPITAL STAY WAS PROLONGED DUE TO THE PNEUMOPERITONEUM. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465045 MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE ENDOSCOPE ODE MEDIGUS LTD SRS05 07290014036062

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| O