BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE

    MDR report key: 8126859 · Received December 3, 2018

    Report

    Report Number
    3004444684-2018-00003
    Event Type
    Injury
    Date Received
    December 3, 2018
    Date of Event
    November 9, 2018
    Report Date
    November 9, 2018
    Manufacturer
    MEDIGUS LTD
    Product Code
    ODE
    UDI-DI
    07290014036086
    PMA / PMN Number
    K132151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE ENDOSTAPLER FUNCTIONED AS EXPECTED DURING THE ENTIRE PROCEDURE. A REVIEW OF MANUFACTURING, DEVICE HISTORY, AND QUALITY CONTROL RECORDS FOUND THAT THE DEVICE MET ALL SPECIFICATIONS AND WAS IN COMPLIANCE. THERE WERE NO FINDINGS TO SUGGEST THAT THE DEVICE CAUSED OR CONTRIBUTED IN ANY WAY TO THE PATIENT'S INJURY.

    Description of Event or Problem · 1

    THE PROCEDURE WAS DONE ON (B)(6) 2018. THE FIRST STAPLING SITE WAS AROUND 4CM FROM THE GASTROESOPHAGEAL JUNCTION (GEJ), THE SECOND SITE WAS PERFORMED CLOSE TO THE LESSER CURVE AT AROUND 4CM FROM THE GEJ ALSO. THE THIRD STAPLING SITE WAS PERFORMED ON THE OPPOSITE SITE AT AROUND 3CM FROM THE GEJ. ON (B)(6) 2018, THE RESULTS OF A CHEST AND ABDOMINAL RX AND CT SCAN INDICATED THAT THERE WAS A PERFORATION ON THE SECOND STAPLING SITE, AND THE THIRD STAPLING SITE WHICH WAS ON THE DIAPHRAGM AND IT WAS NECESSARY TO SURGICALLY CLOSE THE AIR LEAKAGE IN THE ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963992 MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE ENDOSTAPLER ODE MEDIGUS LTD MUSE ENDOSTAPLER 830027 07290014036086

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention