BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWISS LITHOCLAST ULTRA FLEXIBLE PROBE

    MDR report key: 1203180 · Received October 17, 2008

    Report

    Report Number
    3005099803-2008-05331
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFK
    PMA / PMN Number
    K002084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH EXPECTED, THE SUSPECT DEVICE HAS NOT BEEN RECEIVED FOR EVAL, THUS, THE CAUSE OF THE REPORTED MALFUNCTION IS CURRENTLY UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP IN 2008 THAT DURING UNPACKING, A LITHOCLAST ULTRA FLEXIBLE PROBE WAS FOUND TO BE BENT. THERE WAS NO PT INVOLVEMENT. PLEASE NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES. REFER TO MFR REPORT # 3005099803-2008-05330 FOR A DESCRIPTION OF THE SECOND DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWISS LITHOCLAST ULTRA FLEXIBLE PROBE FFK BOSTON SCIENTIFIC CORPORATION M0068407330 11925414

    Patients

    Seq Age Sex Outcome Treatment
    1