BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRGFUS EXABLATE

    MDR report key: 4028120 · Received August 13, 2014

    Report

    Report Number
    9615058-2014-00005
    Event Type
    Injury
    Date Received
    August 13, 2014
    Date of Event
    July 18, 2014
    Report Date
    August 12, 2014
    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 SPECS. REASON OF ADVERSE EVENT IS USER ERROR. INSIGHTEC TRAINING MATERIAL ALREADY EXPLAINS AND ADDRESS IMPROVEMENT OF PROCEDURE. SITE IS GOING TO BE TRAINED FOLLOWING THIS EVENT.

    Description of Event or Problem · 1

    PT UNDERWENT AN UNEVENTFUL MRGFUS PROCEDURE ON (B)(6) 2014, BUT EXPERIENCED SEVERE PAIN IMMEDIATELY AFTER THE PROCEDURE. SHE WAS READMITTED AT (B)(6) ON THE (B)(6) 2014 WITH PAIN AND HAD AN AXR/CXR DEMONSTRATING FECAL LOADING AND NO FRANK OBSTRUCTION/PERFORATION AND A PELVIC ULTRA SOUND DEMONSTRATING A MODERATE AMOUNT OF FREE FLUID/REACTIVE BUT NIL OTHER ABNORMALITY. THE PT WAS AFEBRILE, NORMOTENSIVE, WITHOUT TACHYCARDIA AND HAD A SOFT ABDOMEN WITH PAIN PREDOMINANTLY OVER HER UTERUS. CRP WAS 5, INITIAL WCC 13.5 WHICH 12/24 LATER WAS 5.5. SHE WAS GIVEN APERIENTS FOR CONSTIPATION AND EMPTIED HER BOWELS. SHE WAS DISCHARGED HOME ON THE (B)(6) FEELING BETTER. THE PT SUBSEQUENTLY PRESENTED 36 HOURS LATER WITH AN ACUTE ABDOMEN TO (B)(6), HAD EVIDENCE OF A SMALL BOWEL PERFORATION AT LAPAROTOMY AND UNDERWENT A SMALL BOWEL RESECTION WITH ABDOMINAL CAVITY WASHOUT. AS OF (B)(6) THE PT IS RECOVERING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483404 MRGFUS EXABLATE HIFU NRZ INSIGHTEC LTD. 2000

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| R