BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V

    MDR report key: 2432510 · Received January 19, 2012

    Report

    Report Number
    8010047-2012-00012
    Event Type
    Malfunction
    Date Received
    January 19, 2012
    Date of Event
    December 19, 2011
    Report Date
    December 21, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    LQR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE USER FACILITY REPORTEDLY HAD DISCARDED THE DEVICE FOLLOWING THE PROCEDURE. REVIEW OF COMPLAINT FILE FOR A PERIOD OF 2 YEARS DID NOT IDENTIFY ANY OTHER COMPLAINTS ASSOCIATED WITH THE LOT NUMBER. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED BUT THE SIZE OR HARDNESS OF THE STONE COULD NOT BE RULED OUT AS THE CONTRIBUTING FACTOR OF THE USER'S EXPERIENCE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE SUBJECT DEVICE WAS REPORTEDLY BROKEN AT THE PIPE IN THE PROXIMAL END AS THE LITHOTRIPSY HANDLE WAS CLOSING THE BASKET AROUND A STONE. THE USERS REPORTEDLY ATTEMPTED TO CRUSH THE STONE WITH A SOLENDRA EMERGENCY HANDLE WITHOUT A SUCCESS BUT MANAGED TO REMOVE THE BASKET FROM THE PT. A SIMILAR BUT DIFFERENT DEVICE WAS REPORTEDLY INTRODUCED IN AN ATTEMPT TO CRUSH THE STONE OF WHICH THE DEVICE WAS SAID TO HAVE BROKEN AT THE PIPE IN THE PROXIMAL END AGAIN AND THE SAME SOLENDRA EMERGENCY HANDLE WAS UTILIZED IN WHICH THE PROCEDURE WAS COMPLETED WITH NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V LITHOTRIPTOR LQR OLYMPUS MEDICAL SYSTEMS CORPORATION BML-V442QR-30 17K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK