BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEI MEDICAL SYSTEMS HYDRO THERMABLATOR

    MDR report key: 495571 · Received October 27, 2003

    Report

    Report Number
    495571
    Event Type
    Malfunction
    Date Received
    October 27, 2003
    Date of Event
    March 1, 2003
    Report Date
    October 1, 2003
    Manufacturer
    BOSTON SCIENTIFIC CORP
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MACHINE DID NOT WORK. BACKUP MACHINE ALSO DID NOT WORK. REP TOOK PARTS FROM OTHER MACHINE TO MAKE IT WORK. NO WAY TO TEST PRIOR TO SURGERY. ASKED FOR NON-STERILE PRODUCT TO TEST IN FUTURE. NO DELAY IN SURGERY OTHER THAN ANESTHESIA TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEI MEDICAL SYSTEMS HYDRO THERMABLATOR HYDRO THERMABLATOR MNB BOSTON SCIENTIFIC CORP 56000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR