BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROTHERMABLATOR CONTROL UNIT

    MDR report key: 1140646 · Received August 28, 2008

    Report

    Report Number
    3005099803-2008-04173
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 29, 2008, THAT A HYDROTHERMABLATOR CONTROL UNIT (HTA) WAS USED DURING A THERAPEUTIC HYDROTHERMAL ABLATION PROCEDURE ON SIX DAYS EARLIER. ACCORDING TO THE COMPLAINANT, DURING THE HYSTEROSCOPY PHASE, THE PHYSICIAN TRIED TO PAUSE THE MACHINE BY HITTING STOP; IT WAS NOT REGISTERING AND THEY COULD NOT STOP IT. THE MACHINE WAS TURNED OFF AND ON AGAIN. THE MACHINE WOULD NOT STOP FLOWING. THE CASE WAS ABORTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROTHERMABLATOR CONTROL UNIT MNB BOSTON SCIENTIFIC CORPORATION M006560000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK