BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRGFUS EXABLATE

    MDR report key: 4447821 · Received January 23, 2015

    Report

    Report Number
    9615058-2015-00001
    Event Type
    Injury
    Date Received
    January 23, 2015
    Date of Event
    December 15, 2014
    Report Date
    January 15, 2015
    Manufacturer
    INSIGHTEC LTD.
    Product Code
    NRZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS REVIEWED TO OPERATING WITHIN ITS SPECIFICATIONS. REASON OF ADVERSE EVENT IS USER ERROR. INSIGHTEC TRAINING MATERIAL ALREADY EXPLAINS AND ADDRESS SUCH SITUATIONS. INSIGHTEC FINDINGS WERE PRESENTED AND DISCUSSED WITH THE SITE.

    Description of Event or Problem · 1

    TREATMENT FLOW WAS WITHOUT EXCEPTIONAL EVENTS, ALTHOUGH THE PT STOPPED THE TREATMENT SEVERAL TIMES DUE TO LOWER ABDOMINAL CRAMPS. AT THE END OF THE TREATMENT THE PT WAS DISMISSED WITH MILD CRAMPS AND BLOATING SYMPTOM. DURING THE FOLLOWING TWO DAYS (WEEKEND) THE PATIENT HAD ABDOMINAL PAIN AND ON MONDAY (3 DAYS AFTER THE TREATMENT) SHE WAS OPERATED IN ANOTHER HOSPITAL FOR PERITONITIS. LAPAROTOMY REVEALED A SMALL BOWEL TRANSMURAL PERFORATION; WITH LOCAL SIGNS OF PERITONITIS. THE AREA WITH THE PERFORATION WAS RESECTED WITH PRIMARY ANASTOMOSIS, AND THE ABDOMINAL CAVITY WAS IRRIGATED. POST-SURGERY RECOVERY OF THE PT WAS WITHOUT ANY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55491 MRGFUS EXABLATE HIFU NRZ INSIGHTEC LTD. 2100

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R