BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRGFUS EXABLATE

    MDR report key: 2147572 · Received May 22, 2011

    Report

    Report Number
    9615058-2011-00001
    Event Type
    Injury
    Date Received
    May 22, 2011
    Date of Event
    May 14, 2011
    Report Date
    May 22, 2011
    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 IS USER ERROR. TREATING PHYSICIAN FAILED TO NOTICE ORGANS MOVEMENT. INSIGHTEC TRAINING MATERIAL ALREADY EXPLAINS AND ADDRESS SUCH SITUATIONS THUS WE DID NOT FIND ANY ROOM FOR IMPROVEMENT OF PROCEDURE. SITE WAS RE TRAINED FOLLOWING THIS EVENT. PLEASE SEE FULL ANALYSIS REPORT ATTACHED.

    Description of Event or Problem · 1

    THE PT: A (B)(6) YRS OLD, FEMALE, PRESENTING WITH FIBROID ATTRIBUTABLE MENORRHAGIA AND ABDOMINAL PAIN DURING THE LAST YEAR. MRI REVEALED AN INTRAMURAL POSTERIOR FIBROID, VOLUME OF APPROX 50CC (41MM X 41MM X 53MM); HYPO-INTENSE ON T2W IMAGING. TREATMENT WAS PLANNED FOR A SINGLE SESSION, BUT AT THE END OF THE FIRST SESSION THE TREATING PHYSICIANS FOUND OUT THAT A SIGNIFICANT PORTION OF THE FIBROID REMAINED PERFUSED AND DECIDED COMPLETE THE TREATMENT IN A SECOND SESSION ON THE FOLLOWING DAY (SINCE THE PT LIVES FAR FROM THE HOSP). TREATMENT SESSIONS TOOK PLACE ON (B)(6), 2011 AND (B)(6), 2011. BOTH TREATMENT SESSIONS WERE DESCRIBED AS UNEVENTFUL. THE PT WAS PLANNED TO STAY AT THE HOSP OVERNIGHT (WHICH IS STANDARD OF CARE IN (B)(6)). SHE WAS EXPECTED TO BE DISCHARGED ON (B)(6). HOWEVER, DUE TO COMPLAINTS ABOUT SPASTIC ABDOMINAL PAIN, THE PT REMAINED ANOTHER NIGHT FOR OBSERVATION IN THE HOSP. IN THE MORNING OF (B)(6), THE PT STILL COMPLAINED ABOUT ABDOMINAL PAIN AND HER MEASURED PULSE WAS APPROX 105 BPM, AND CT REVEALED AIR IN THE ABDOMINAL CAVITY SUGGESTING BOWEL PERFORATION. THE PT UNDERWENT EMERGENCY LAPAROTOMY WHERE A TERM...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MRGFUS EXABLATE FOCUSED ULTRASOUND NRZ INSIGHTEC LTD. 2100

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R