BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRGFUS EXABLATE

    MDR report key: 3335967 · Received September 5, 2013

    Report

    Report Number
    9615058-2013-00001
    Event Type
    Injury
    Date Received
    September 5, 2013
    Date of Event
    December 12, 2012
    Report Date
    January 24, 2012
    Manufacturer
    INSIGHTEC LTD
    Product Code
    NRZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS BEEN DIAGNOSED TO WORK ACCORDING TO IT'S SPECIFICATIONS. REASON OF ADVERSE EVENT MAY BE DEFINED AS USER ERROR. TREATING PHYSICIAN FAILED TO NOTICE SKIN HEATING. INSIGHTEC TRAINING MATERIAL ALREADY EXPLAINS AND ADDRESS SUCH SITUATIONS THUS WE DID NOT FIND ANY ROOM FOR IMPROVEMENT OF PROCEDURE. INCIDENT DISCUSSED WITH THE SITE. SUMMARY: THERE WAS NO DEVICE MALFUNCTION OR DETERIORATION THAT WOULD HAVE CAUSED THIS EVENT. OUR DETAILED ANALYSIS OF THIS PARTICULAR CASE SHOWS THAT STARTING FROM SONICATION #15, WE SEE SEVERAL SONICATIONS SHOWING TEMPERATURE RISE ON THE GEL PAD - SKIN INTERFACE, AND SOME SHOWING SKIN HYPEREMIA ON THE MAGNITUDE FAT SATURATED IMAGES. OTHERWISE, THERE WERE NO UNUSUAL FINDINGS IN PT POSITIONING, TREATMENT PLANNING OR TREATMENT PARAMETERS. BECAUSE OF THE SKIN BURN LOCATION, I.E.: GEL PAD-SKIN INTERFACE, WE CAN ONLY ASSUME THAT THE ACOUSTIC COUPLING BETWEEN THE PT AND THE GEL PAD AROUND THE LOCATION OF THE SKIN WAS PROBLEMATIC. BASED ON INSIGHTEC PAST EXPERIENCE WITH THESE TYPE OF EVENTS, THIS COULD HAVE BEEN INDUCED BY MICROSCOPIC AIR BUBBLES, OR HYDROPHOBIC SKIN (I.E. SKIN WAS NOT PROPERLY CLEANED FROM POTENTIAL OIL BASED BY-PRODUCTS). IN ANY EVENT, THE TREATING PHYSICIAN DID NOT NOTICE THE EFFECTS THAT WERE DISPLAYED ON THE MR IMAGES FOLLOWING SONICATION#15 AND UP. ACTION FOLLOWING THIS REAL TIME FEEDBACK COULD HAVE HELPED MINIMIZE THE EVENT. SKIN BURN EVENTS ARE WELL KNOWN RISKS FOR THE FOCUSED ULTRASOUND PROCEDURE. HOWEVER, THE STEPS TO ELIMINATE THEM ARE ALSO WELL KNOWN. IN FACT, SINCE THE IMPLEMENTATION OF ALL THE MITIGATING STEPS IN OUR INSIGHTEC TRAINING, THESE EVENTS ARE INDEED FAIRLY RARE. IN RESPONSE TO THIS PARTICULAR CASE, INSIGHTEC APPLICATION TEAM WILL REACH OUT TO THE TREATING PHYSICIAN TO RE-EMPHASIZE THE ROLE OF THE REAL TIME MR INTRA-PROCEDURE IMAGING, AS WELL AS FULL REVIEW OF THE STEPS TO MITIGATE THIS TYPE OF EVENTS. IT SHOULD BE NOTED THAT THIS PARTICULAR TREATING PHYSICIAN HAS TREATED MORE THAN 300 PTS AT A RATE OF 1 TO 2 PTS A DAY, AND THIS IS THE FIRST TIME THEY ENCOUNTERED SUCH AN EVENT.

    Description of Event or Problem · 1

    PT RECEIVED A UTERINE FIBROID TREATMENT ON (B)(6) 2013 BY DR (B)(6) AT (B)(6). PT WAS DIAGNOSED WITH SKIN REDNESS AND SMALL BLISTERS RESEMBLE SKIN BURN OF 1ST OR 2ND DEGREE. PT WAS RELEASED HOME WITH FLAMMAZINE (BURN TREATMENT OINTMENT) . IT WAS REPORTED FOLLOWING BLISTERS INFECTION, PT WAS ADMITTED IN THE SPECIAL UNIT FOR SKIN BURNS AT (B)(6) HOSPITAL. PT UNDERWENT SURGICAL RESECTION OF THE BURNED TISSUE ON THE ABDOMINAL SURFACE. SURGERY WENT WELL WITHOUT COMPLICATIONS. CURRENTLY PT IS RECOVERING AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440766 MRGFUS EXABLATE FOCUSSED ULTRASOUND NRZ INSIGHTEC LTD 2100

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R