BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROTHERMABLATOR PROCEDURE SET

    MDR report key: 1423768 · Received April 3, 2009

    Report

    Report Number
    3005099803-2009-01562
    Event Type
    Malfunction
    Date Received
    April 3, 2009
    Date of Event
    March 6, 2009
    Report Date
    March 6, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION: THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDROTHERMABLATOR PROCEDURE SET WAS USED DURING A ENDOMETRIAL ABLATION PROCEDURE PERFORMED IN 2009. DURING THE HYSTEROSCOPY PHASE OF THE PROCEDURE, AFTER THE INITIAL 2 MINUTES, THE NURSE PRESSED THE BUTTON FOR MORE HYSTEROSCOPY TIME. THE MACHINE RAN FRO 5 SECONDS AND THEN STOPPED. THE SCREEN FROZE AND THE FLUID STOPPED CIRCULATING THROUGH THE SYSTEM. THEY REMOVED THE PROCEDURE SET AND USED ANOTHER OF THE SAME DEVICE AND COMPLETED THE CASE WITH NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROTHERMABLATOR PROCEDURE SET MNB BOSTON SCIENTIFIC CORPORATION M00650201 0000036234

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK