BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE

    MDR report key: 6677619 · Received June 29, 2017

    Report

    Report Number
    3004444684-2017-00001
    Event Type
    Injury
    Date Received
    June 29, 2017
    Date of Event
    June 5, 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

    Description of Event or Problem · 1

    THE FIRST DAY AFTER SURGERY ((B)(6) 2017), THE PATIENT HAD THROAT DISCOMFORT, WITH A SLIGHT DISCOMFORT OF SUBSTERNAL ESOPHAGUS AND MIDDLE & UPPER ABDOMINAL REGION. THERE WAS NO FEVER OR ABDOMINAL PAIN BUT SINCE HER BLOOD LEUCOCYTES WERE HIGH, SHE WAS PLACED ON AN INTRAVENOUS INFUSION OF CEFAZOLIN FOR ANTI-INFECTION TREATMENT. LATER, THE PATIENT DID HAVE A FEVER, THE HIGHEST TEMPERATURE BEING 38.3 DEGREES CELSIUS. THE SYMPTOMS WERE MARKED BY THROAT PAIN WITH A SLIGHT DISCOMFORT IN THE POSTERIOR ESOPHAGUS AND THE MIDDLE AND UPPER ABDOMEN AND FATIGUE. THE PATIENT REFUSED TO HAVE A CHEST AND ABDOMINAL CT DONE TO DETERMINE THE REASON FOR THE SYMPTOMS SO THE HOSPITAL CONTINUED THE ANTIBIOTICS, ANTI-INFLAMMATORY DRUGS TREATMENT, AND PPI DRUGS TO PROTECT THE STOMACH. THE FEVER LASTED FOR MORE THAN THREE DAYS; THEN THE BODY TEMPERATURE RETURNED TO NORMAL AND THE SYMPTOMS GRADUALLY DISAPPEARED. ON THE SIXTH DAY ((B)(6)), THE BLOOD TESTS WERE NORMAL. THE PATIENT REMAINED ON INTRAVENOUS ANTIBIOTICS FOR ANOTHER TWO DAYS AND THEN WAS DISCHARGED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457078 MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE ENDOSCOPE ODE MEDIGUS LTD SRS05 07290014036062

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| O