BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRGFUS EXABLATE

    MDR report key: 3876312 · Received June 4, 2014

    Report

    Report Number
    9615058-2014-00003
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    May 25, 2014
    Report Date
    May 25, 2014
    Manufacturer
    INSIGHTEC LTD.
    Product Code
    NRZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOR LEGAL REASONS, THE CUSTOMER WAS NOT ABLE TO PROVIDE ADDITIONAL DETAIL, WHEN REQUESTED BY INSIGHTEC. DUE TO THE LACK OF ADDITIONAL INFORMATION FROM THE CUSTOMER, INSIGHTEC CANNOT CONCLUDE WHETHER OR NOT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THIS INJURY. IN AN ABUNDANCE OF CAUTION, THE COMPANY IS SUBMITTING THIS MDR REPORT BASED SOLELY ON THE INITIAL LIMITED INFORMATION PROVIDED TO THE COMPANY. IT SHOULD BE NOTED THAT THE REVIEW OF THE DEVICE HISTORY DID NOT SHOW ANY MALFUNCTION NOR DEVIATION FROM THE DEVICE NORMAL OPERATING SPECIFICATIONS.

    Description of Event or Problem · 1

    IN COMPLIANCE WITH REGULATORY REQUIREMENTS SUCH AS THOSE IN EUROPE, INSIGHTEC INITIATED A POST MARKETING SURVEILLANCE QUESTIONNAIRE TO CAPTURE CUSTOMERS FEEDBACK. ONE OF OUR CUSTOMERS, DR. (B)(6), CITED IN THEIR FEEDBACK THAT ONE OF THIS PATIENTS REPORTED A BOWEL PERFORATION. THEY ALSO ADDED THAT THEIR PATIENT SUFFERED WITH CHRONIC INFLAMMATORY DISEASE OF THE BOWEL. PATIENT WAS TREATED FOR THEIR UTERINE FIBROIDS WITH THE EXABLATE DEVICE. FOR LEGAL REASON, WE COULD NOT GET ANY ADDITIONAL DATA FROM THE SITE. HOWEVER, WE HAVE REVIEWED LAST YEAR SERVICE CALLS, DEVICE MAINTENANCE FILES AND ACTIONS AND FOUND NO ISSUES THAT COULD SUGGEST DEVICE HAS NOT BEEN WORKING ACCORDING TO ITS ORIGINAL SPECIFICATIONS AND OR THAT DEVICE EXPERIENCED DETERIORATION. HENCE, AT THIS TIME, WE ARE UNABLE TO MAKE A FULL REVIEW OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325655 MRGFUS EXABLATE HIFU NRZ INSIGHTEC LTD. 2100

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R