BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRUCLEAR

    MDR report key: 4844319 · Received June 3, 2015

    Report

    Report Number
    4844319
    Event Type
    Death
    Date Received
    June 3, 2015
    Date of Event
    May 14, 2015
    Report Date
    May 26, 2015
    Manufacturer
    SMITH AND NEPHEW
    Product Code
    HIH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT ADMITTED FOR ELECTIVE REMOVAL OF UTERINE FIBROIDS. THIS WAS SCHEDULED AS A TWO PART PROCEDURE (HYSTEROSCOPY/LAPAROSCOPY). AFTER APPROXIMATELY 2500 ML SALINE DEFICIT, NO FURTHER FLUID WAS ADDED AND DECISION WAS MADE TO DISCONTINUE THE HYSTEROSCOPY PROCEDURE. THE PATIENT WAS NOTED TO BE STABLE. AFTER FINAL CALIBRATION OF HYSTEROSCOPY FLUID AT THIS POINT, APPROXIMATELY 3000 ML NORMAL SALINE BALANCE WAS NOTED. ALL INSTRUMENTS WERE REMOVED FROM THE PATIENT'S UTERUS. EXCELLENT HEMOSTASIS WAS NOTED. ONCE THEY STARTED PULLING BACK THE TRUCLEAR TOWER, THERE WAS A CHANGE IN THE PATIENT'S VITAL SIGNS AND CODE BLUE WAS CALLED. PATIENT WAS PLACED ON ECMO AND A DIAGNOSTIC LAPAROTOMY WAS PERFORMED IN THE OPERATING ROOM. THE PATIENT WAS TRANSFERRED TO THE ICU, WHERE SHE LATER EXPIRED. THE EQUIPMENT USED ARE AS FOLLOWS: HYSTEROSCOPIC FLUID MONITOR SYSTEM REF: 7210165, SN: (B)(4). VACUUM REGULATOR MODEL: PM3600, SN: (B)(4). HYSTEROSCOPIC FLUID MANAGEMENT SYSTEM CONTROL UNIT, REF: 7210164, SN: (B)(4). TRUCLEAR CONTROL UNIT REF: 7209808, SN: (B)(4). FOOTPEDAL REF: 7209820, SN: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360864 TRUCLEAR MORCELLATOR HIH SMITH AND NEPHEW NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death