BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIRCON/ACMI HYSTEROSCOPE ADAPTER

    MDR report key: 1083226 · Received July 24, 2008

    Report

    Report Number
    3005099803-2008-01273
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE USED IS UNKNOWN, CONSEQUENTLY, THE MANUFACTURE AND EXPIRATION DATE OF THE DEVICE IS UNKNOWN. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION SINCE IT WAS DISPOSED OF; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE. THE COMPLAINT ALLEGES THAT THE ADAPTER HAD A SLOW LEAK. A DHR REVIEW WAS NOT PERFORMED BECAUSE THE BATCH IS UNKNOWN HOWEVER THERE ARE NO KNOWN MANUFACTURING RELATED ISSUES WHICH WOULD CONTRIBUTE TO THIS EVENT AND THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE HISTORY AND THE EVENT DESCRIPTION DID NOT PROVIDE ENOUGH INFORMATION TO FORMULATE A DEFINITIVE ROOT CAUSE. TYPICALLY LEAKS AT THE ADAPTER CAN BE CAUSE BY THE ADAPTER NOT BE PROPERLY TIGHTENED OR THE SHAPE OF THE ADAPTER BEING CHANGED DUE TO STERILIZATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PATIENT UNDERWENT A THERAPEUTIC HYDROTHERMAL ABLATION (HTA) PROCEDURE THAT OCCURRED IN 2008. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE A SLOW LEAK WAS NOTICED FROM THE SCOPE ADAPTER. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIRCON/ACMI HYSTEROSCOPE ADAPTER MNB BOSTON SCIENTIFIC CORPORATION M006550350

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK