BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUSE - MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER

    MDR report key: 5680490 · Received May 25, 2016

    Report

    Report Number
    3004444684-2016-00003
    Event Type
    Injury
    Date Received
    May 25, 2016
    Date of Event
    April 21, 2016
    Report Date
    April 29, 2016
    Manufacturer
    MEDIGUS, LTD.
    Product Code
    ODE
    PMA / PMN Number
    K132151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE PERFORMED AS INTENDED. NO MALFUNCTION OR DEFECT OF DEVICE NOTED. (B)(4). MANUFACTURER: MEDIGUS LTD (B)(4). IMPORTER: (B)(4). MDR EXEMPTION E2013040.

    Description of Event or Problem · 0

    A MUSE ENDOSCOPIC PROCEDURE FOR THE TREATMENT OF GERD WAS SUCCESSFULLY COMPLETED. THE NEXT DAY, THE PATIENT DEVELOPED A FEVER. HE WAS TREATED WITH ANTIBIOTICS (METRONIDAZOLE) FOR THREE MORE DAYS BUT THE FEVER DID NOT RESOLVE. A CHEST X RAY SHOWED MILD PNEUMOMEDIASTINUM. AN ABDOMINAL AND CHEST CT SCAN DONE ON THE FOURTH DAY SHOWED BILATERAL PLEURAL EFFUSION, ATELECTASIS, MEDIASTINITIS AND A LEAKAGE OF CONTRAST SUBSTANCE TO THE MEDIASTINUM. AN ENDOSCOPY WAS PERFORMED BUT REVEALED NO PERFORATION. ON THE FIFTH DAY POST PROCEDURE, THE PATIENT HAD A BILATERAL CHEST TUBE INSERTION TO DRAIN THE PLEURAL EFFUSION AND A LAPAROSCOPIC PROCEDURE DURING WHICH A SMALL PERFORATION WAS IDENTIFIED. THE SURGEON NOTICED THAT PUS WAS DRAINING FROM THE PERFORATION DUE TO MEDIASTINUM ABSCESS. HE DRAINED THE MEDIASTINAL ABSCESS, THEN SUTURED AND PATCHED THE ESOPHAGEAL PERFORATION. PATIENT IMPROVED CLINICALLY AFTER THE PROCEDURES AND FEVER SUBSIDED. AS OF LAST CLINICAL UPDATE ON (B)(6), THE PATIENT WAS DOING FINE, HAD NO FEVER AND WHITE BLOOD CELL COUNT WAS IN NORMAL RANGE. CONCLUSION: MEDIASTINAL ABSCESS DUE TO ESOPHAGEAL PERFORATION. STAPLING OF DIAPHRAGM CRUSES CREATED TENSION THAT LED TO PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333977 MUSE - MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER ENDOSTAPLER ODE MEDIGUS, LTD. SRS05

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention