BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V

    MDR report key: 3894256 · Received February 14, 2014

    Report

    Report Number
    2951238-2014-00055
    Event Type
    Malfunction
    Date Received
    February 14, 2014
    Date of Event
    January 28, 2014
    Report Date
    January 29, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP
    Product Code
    FEO
    PMA / PMN Number
    K903529
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN YET RETURNED TO OLYMPUS FOR EVAL. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADD'L AND SIGNIFICANT INFO BECOMES AVAILABLE LATER.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE USER ATTEMPTED TO CRUSH THE BILIARY STONE AND THE WIRES ON THE BASKET BROKE. THE DEVICE WAS SAFELY REMOVED FROM THE PT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT INSTRUMENT. THERE WAS NO PT INJURY REPORTED. OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THE REPORT BUT NO ADD'L INFO WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97805 OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V LITHOTRIPTOR FEO OLYMPUS MEDICAL SYSTEMS CORP BML-V442QR-30 3XK

    Patients

    Seq Age Sex Outcome Treatment
    1