BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    MDR report key: 3062559 · Received April 17, 2013

    Report

    Report Number
    3005099803-2013-02427
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Report Date
    March 21, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED HYDRO THERMALATOR (HTA) ENDOMETRIAL ABLATION SYSTEM REVEALED THE UNIT PASSED A SAFETY AND CURRENT TEST. THE CONSOLE WAS OPENED AND VISUALLY INSPECTED FOR LOOSE CONNECTIONS AND LOOSE OR MISSING HARDWARE. NO LOOSE CONNECTIONS OR LOOSE OR MISSING HARDWARE WAS FOUND. FURTHERMORE, THIS EVENT IS DETERMINED TO NOT BE MDR REPORTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM WAS BEING INSPECTED BY THE BIOMEDICAL DEPARTMENT PRIOR TO A PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE UNIT FAILED THE GROUNDING TEST DUE TO A LOOSE POWER CORD. THERE WAS NO PATIENT INVOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM WAS BEING INSPECTED BY THE BIOMEDICAL DEPARTMENT PRIOR TO A PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE UNIT FAILED THE GROUNDING TEST DUE TO A LOOSE POWER CORD. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164540 HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC - FREMONT (CE) M00658001R0

    Patients

    Seq Age Sex Outcome Treatment
    1