BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS ULTRASONIC LITHOTRIPTOR PROBE

    MDR report key: 1772226 · Received July 22, 2010

    Report

    Report Number
    8010047-2010-00147
    Event Type
    Other
    Date Received
    July 22, 2010
    Date of Event
    June 22, 2010
    Report Date
    June 22, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE PROBE WAS RETURNED IN TWO PIECES, AND WAS FOUND TO BE FRACTURED APPROXIMATELY 80 MM FROM THE BASE OF THE PROBE. THERE WERE DEEP SCRAPES AND INDENTATIONS ON THE EXTERIOR SURFACES OF PROBE NEAR THE FRACTURE JOINT. BASED UPON THE FINDINGS, IT APPEARS THAT THE PROBE CONTACTED A HARD SURFACE WHILE BEING OPERATED. THE PROBE WILL BE FORWARDED TO THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR FURTHER INVESTIGATION. (B)(4). THIS MEDICAL DEVICE REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC LITHOTRIPSY, THE PHYSICIAN ATTEMPTED TO REMOVE THE ULTRASONIC LITHOTRIPTOR FROM THE PATIENT, AND NOTED THAT A QUARTER OF THE DEVICE HAD REMAINED IN THE HANDPIECE, WITH THE OTHER SECTION REMAINING IN A SINGLE LARGE PIECE IN THE PATIENT. THE REMAINING PIECE REPORTEDLY EXTENDED OUT OF THE PATIENT. THE PORTION OF THE DEVICE THAT REMAINED IN THE PATIENT DID NOT HAVE SHARP EDGES, AND WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER HANDPIECE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS ULTRASONIC LITHOTRIPTOR PROBE ULTRASONIC LITHOTRIPTOR PROBE FEO OLYMPUS MEDICAL SYSTEMS CORPORATION MAJ-985 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1