BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LITHOCLAST ULTRASOUND PROBE

    MDR report key: 1328030 · Received March 3, 2009

    Report

    Report Number
    3005099803-2008-06351
    Event Type
    Malfunction
    Date Received
    March 3, 2009
    Date of Event
    August 1, 2007
    Report Date
    August 3, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION-SPENCER
    Product Code
    FFK
    PMA / PMN Number
    K973788
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE IS UNKNOWN; CONSEQUENTLY, THE MANUFACTURE DATE AND EXPIRATION DATE CANNOT BE DETERMINED. CUSTOMER COMPLAINT CONFIRMED. THE PROBE IS BROKE AT THE THREADS ON THE PROXIMAL END. THE ROOT CAUSE FOR THE BREAKAGE OF THE PROBE IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE, THE CONNECTOR BETWEEN THE PROBE AND THE HANDPIECE BROKE. THE PROBE REMAINED ATTACHED TO THE HANDPIECE THROUGHOUT THE PROCEDURE, AND THE BREAKAGE WASN'T DISCOVERED UNTIL THE PROBE WAS SWAPPED OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER PROBE, WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "FINE" POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LITHOCLAST ULTRASOUND PROBE LITHOTRIPTOR, ELECTRO-HYDRAULIC FFK BOSTON SCIENTIFIC CORPORATION-SPENCER M0068407160

    Patients

    Seq Age Sex Outcome Treatment
    1