BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LITHOCLAST ULTRASOUND PROBE

    MDR report key: 1333194 · Received March 5, 2009

    Report

    Report Number
    3005099803-2008-01914
    Event Type
    Malfunction
    Date Received
    March 5, 2009
    Date of Event
    October 4, 2005
    Report Date
    October 11, 2005
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION-SPENCER
    Product Code
    FFK
    PMA / PMN Number
    K973788
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER; THEREFORE, A FAILURE ANALYSIS COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION, THAT A LITHOCLAST ULTRASOUND PROBE WAS CHECKED DURING INVENTORY AND IT WAS FOUND THAT THE PACKAGING WAS NOT SEALED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LITHOCLAST ULTRASOUND PROBE MICROVASIVE LITHOTRIPTOR PROBE FFK BOSTON SCIENTIFIC CORPORATION-SPENCER M0068407310 7581741

    Patients

    Seq Age Sex Outcome Treatment
    1