BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUCLEAR HYSTERSCOPY SYSTEM (FLUID MANAGEMENT AND INSTRUMENT

    MDR report key: 1945083 · Received December 23, 2010

    Report

    Report Number
    1945083
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    August 17, 2010
    Report Date
    December 23, 2010
    Manufacturer
    SMITH AND NEPHEW
    Product Code
    HIH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE TRUCLEAR HYSTEROSCOPIC MORCELLATOR SYSTEM AND SALINE DISTENSION MEDIUM WERE USED ON THE PATIENT TO VISUALIZE AND RESECT A UTERINE FIBROID MEASURING APPROXIMATELY 4CM. DURING THE PROCEDURE, THE SURGEON REPORTED DIFFICULTY WITH RESECTION DUE TO INSENSIBLE FLUID LOSSES AND NOT HAVING A CLEAR IDEA OF HOW MUCH FLUID WAS BEING ABSORBED AND HOW MUCH WAS LOST IN THE DRAPING MATERIAL AND FLOOR. PER THE FLUID MANAGEMENT SYSTEM, THE FLUID DEFICIT WAS ESTIMATED TO BE 7150ML. THE SURGEON ESTIMATED THE FLUID DEFICIT TO BE 2000ML. AT THIS TIME, THE SURGEON CHOSE TO CHANGE TO AN ALTERNATE PRODUCT AND CONVERT THE CASE TO AN OPEN HYSTERECTOMY (BLEEDING). THE PATIENT WAS SYMPTOMATIC FOR INTRAVASATION AND FLUID OVERLOAD REQUIRING ADMISSION.====================== MANUFACTURER RESPONSE FOR OPERATIVE HYSTEROSCOPY SYSTEM AND SET, TRUCLEAR HYSTEROSCOPY SYSTEM (FLUID MANAGEMENT AND INSTRUMENTS)======================UNKNOWN. FIELD REPRESENTATIVE MADE AWARE OF FUNCTIONAL CONCERNS OF DEVICE FROM OUR MATERIALS MANAGEMENT LEAD WHEN RETURNED ON 8/25/2010 .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUCLEAR HYSTERSCOPY SYSTEM (FLUID MANAGEMENT AND INSTRUMENT OPERATIVE HYSTEROSCOPY SYSTEM AND SET HIH SMITH AND NEPHEW * *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR