BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROTHERMABLATOR CONSOLE UNIT

    MDR report key: 1160022 · Received September 12, 2008

    Report

    Report Number
    3005099803-2008-04518
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 12, 2008
    Report Date
    August 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SERVICED AT THE CUSTOMER SITE, THEREFORE, IT WILL NOT BE RETURNED TO THE MANUFACTURER. THE HTA PROCEDURE SET HEATER CANISTER WAS REPLACED AND RESOLVED THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008 THAT A HYDROTHERMABLATOR CONSOLE UNIT (HTA) WAS USED DURING A HYDROTHERMABLATOR (HTA) PROCEDURE ON THE DAY BEFORE. ACCORDING TO THE COMPLAINANT, THE HTA PROCEDURE SET HEATER CANISTER MELTED. THE ISSUE OCCURRED DURING SET UP BEFORE THE REST OF THE KIT CONNECTED. THE ROD INSIDE THE HEATER CANISTER WAS GLOWING AND MELTED BENT OVER. THE HTA PROCEDURE WAS COMPLETED WITH ANOTHER HTA PROCEDURE SET. THERE IS NO FURTHER INFORMATION AVAILABLE REGARDING THE PATIENT OR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROTHERMABLATOR CONSOLE UNIT MNB BOSTON SCIENTIFIC CORPORATION M00656000R0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK