BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LITHOCLAST ULTRA ULTRASOUND PROBE

    MDR report key: 1171463 · Received September 17, 2008

    Report

    Report Number
    3005099803-2008-04668
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFK
    PMA / PMN Number
    K973788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED BY THIS MANUFACTURER. AN EVALUATION HAS NOT BEEN PERFORMED; 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 THAT A LITHOCLAST ULTRA ULTRASOUND PROBE WAS FOUND TO BE BENT INSIDE THE PACKAGE. THE PACKAGING ITSELF WAS INTACT AND UNDAMAGED. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LITHOCLAST ULTRA ULTRASOUND PROBE FFK BOSTON SCIENTIFIC CORPORATION M0068407150 11919691

    Patients

    Seq Age Sex Outcome Treatment
    1