BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE

    MDR report key: 6725212 · Received July 19, 2017

    Report

    Report Number
    3004444684-2017-00003
    Event Type
    Injury
    Date Received
    July 19, 2017
    Date of Event
    June 25, 2017
    Report Date
    June 25, 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

    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. BASED ON A REVIEW OF CLINICAL RECORDS, IT WAS NOT CLEAR WHAT THE FINAL DIAGNOSIS WAS OR WHAT CAUSED THE ADVERSE EVENT.

    Description of Event or Problem · 1

    THE FIRST DAY AFTER THE PROCEDURE WAS COMPLETED ((B)(6) 2017), THE PATIENT COMPLAINED OF SUDDEN CHEST DISCOMFORT AND FEVER (38 DEGREES CELSIUS.) SEVERAL TESTS WERE DONE TO DETERMINE THE CAUSE. THE CHEST CT SCAN SHOWED PNEUMOMEDIASTINUM AT THE LOWER ESOPHAGEAL REGION. THE PATIENT WAS TREATED WITH NEXIUM (ACID SUPPRESSION DRUG), AVELOX (ANTI-INFLAMMATORY DRUG), SULPERAZONE (INTRAVENOUS ANTIBIOTIC) AND A NASOGASTRIC TUBE WAS INSERTED. DURING THE NIGHT OF (B)(6), THE PATIENT'S SELF-REPORTED DISCOMFORT DISAPPEARED. THE PATIENT HAD NO FEVER THE SECOND DAY ((B)(6)) AND BODY TEMPERATURE DID NOT EXCEED 37.4 DEGREES. ON THE THIRD DAY ((B)(6)), THE PATIENT'S HIGHEST TEMPERATURE WAS 38.5 DEGREES CELSIUS. A SECOND CT SCAN SHOWED INFERIOR LOBE CONSOLIDATION AND BILATERAL PLEURAL EFFUSION. THERE WAS NO MEDIASTINAL EMPHYSEMA. ON THE FOURTH DAY ((B)(6)), THE PATIENT STILL HAD AN ELEVATED WHITE BLOOD CELL COUNT. ON THE FIFTH DAY ((B)(6)), THE PATIENT'S BODY TEMPERATURE RETURNED TO NORMAL. ON THE SIXTH DAY ((B)(6)), THE PATIENT HAD NO CHEST OR ABDOMINAL DISCOMFORT AND BEGAN EATING. HE WAS DISCHARGED FROM THE HOSPITAL ON (B)(6), AFTER ELEVEN DAYS OF HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506724 MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE ENDOSCOPE ODE MEDIGUS LTD SRS05 07290014036062

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R