BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE

    MDR report key: 7430689 · Received April 13, 2018

    Report

    Report Number
    3004444684-2018-00001
    Event Type
    Injury
    Date Received
    April 13, 2018
    Date of Event
    March 13, 2018
    Report Date
    March 18, 2018
    Manufacturer
    MEDIGUS LTD
    Product Code
    ODE
    UDI-DI
    07290014036062
    PMA / PMN Number
    K132151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE WAS NOT RETURNED, NO CONCLUSION CAN BE MADE REGARDING WHETHER THE DEVICE CONTRIBUTED TO THE EVENT. HOWEVER, A REVIEW OF MANUFACTURING, DEVICE HISTORY, AND QUALITY CONTROL RECORDS FOUND THAT THE DEVICE MET ALL SPECIFICATIONS AND WAS IN COMPLIANCE.

    Description of Event or Problem · 1

    THE PATIENT IS AN ACTIVE (B)(6) YEAR OLD WOMAN IN GENERAL GOOD HEALTH EXCEPT AS NOTED IN "OTHER RELEVANT HISTORY." THE PROCEDURE WAS UNEVENTFUL. ON THE DAY AFTER THE PROCEDURE, SHE COMPLAINED OF SHORTNESS OF BREATH AND RETROSTERNAL PAIN. THERE WERE NO CLINICAL SIGNS OF AN INFLAMMATORY RESPONSE BUT A CT SCAN DISCLOSED SMALL PNEUMOMEDIASTINUM AND PLEURAL EFFUSION. A CHEST DRAIN WAS PLACED AND A SMALL AMOUNT OF CLEAR FLUID WAS DRAINED. THE FLUID WAS A TRANSUDATE (PROTEIN<3). THE CHEST DRAIN WAS REMOVED ON DAY TWO AND THERE WAS NO RADIOLOGICAL EVIDENCE OF CONTINUING LEAKAGE. ALTHOUGH THE CHEST PAIN RESOLVED, THE PATIENT CONTINUED TO COMPLAIN OF EPIGASTRIC PAIN AND WAS FOUND TO HAVE A NEW DUODENAL ULCER FOR WHICH SHE IS NOW RECEIVING TREATMENT. THE PATIENT MAY HAVE DEVELOPED THE ULCER BECAUSE SHE STOPPED TAKING THE PPI SINCE SHE NO LONGER HAD GERD SYMPTOMS. THE EVENT WAS DEEMED AS PROCEDURE RELATED RATHER THAN DEVICE RELATED BY THE MEDICAL DIRECTOR FOR THE HOSPITAL. ALSO, DUE TO THE HIGH PREVALENCE OF H. PYLORI CONTAMINATION IN (B)(6), SCREENING FOR H. PYLORI COLONIZATION BEFORE THE PROCEDURE WAS STRONGLY RECOMMENDED. THE PROCEDURE CAN BE DONE AFTER ERADICATION OF H. PYLORI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273770 MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE ENDSTAPLER ODE MEDIGUS LTD MUSE ENDOSTAPLER 07290014036062

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization