BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUCLEAR

    MDR report key: 4792630 · Received May 22, 2015

    Report

    Report Number
    3003604053-2015-00012
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    March 27, 2015
    Report Date
    April 24, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH UF/IMPORTER REPORT #(B)(4) WAS RECEIVED ON 24APR2015, AND THE REPORT STATES THE FOLLOWING: DURING A ROUTINE D&C HYSTEROSCOPY USING THE TRUCLEAR SYSTEM, THE SURGEON BECAME AWARE THAT THE UTERUS MAY HAVE BEEN PERFORATED. THE OR STAFF AND SURGEON TRANSITIONED TO A LAPAROSCOPY. THERE WAS AN INADVERTENT UTERINE PERFORATION MOST LIKELY SURROUNDING THE UTERINE CANAL. THE PERFORATION SITE WAS HEMOSTATIC IN THE UTERUS AND THE PERITONEAL CAVITY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE SURGERY. IT IS UNKNOWN IF THE PATIENT WAS DIAGNOSED WITH ANTIFLEXION OR RETROFLEXION OF THE CERVICAL CANAL. DURING THE PROCEDURE, THE HYSTEROSCOPIC TRUCLEAR INSTRUMENTS WERE CALIBRATED AND THEN THE HYSTEROSCOPE WAS PLACED THROUGH THE OPEN CERVIX. DIRECT VISUALIZATION INTO THE UTERINE CAVITY CONFIRMED THE PRESENCE OF BLOOD CLOTS THAT WERE CONSISTENT WITH THE PATIENT'S MEDICAL HISTORY OF HAVING A VERY HEAVY MENSTRUAL CYCLE AT THE TIME OF SURGERY, AND A SMALL (LESS THAN 1 CM) LACERATION NOTED ON THE PATIENT'S RIGHT POSTERIOR UTERINE WALL. WHEN THE UTERINE CAVITY DID NOT DISTEND WELL AND FLUID DEFICIT BEGAN TO INCREASE RAPIDLY, IT WAS DECIDED THAT THIS WAS MOST LIKELY A THROUGH AND THROUGH PERFORATION; THE HYSTEROSCOPE WAS THEN REMOVED AND THE PROCEDURE WAS TERMINATED. THE PATIENT DID NOT HAVE PRIOR HISTORY OF INTRAUTERINE ADHESIONS. THE PATIENT DID NOT ENCOUNTER ANY ADVERSE CONSEQUENCES DURING THE FIRST 24 HOURS POST-PROCEDURE AND THEY HAVE FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333883 TRUCLEAR TRUCLEAR SYSTEM HIH SMITH & NEPHEW, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention