BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V

    MDR report key: 3961375 · Received May 30, 2014

    Report

    Report Number
    8010047-2014-00274
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    LQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICES WERE NOT RETURNED TO OMSC FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THAT THE PIPE WAS BROKEN AT THE JUNCTION WITH THE WIRE. THERE WERE NO ABNORMALITIES FOUND UPON INVESTIGATION OF THE CONDITION OF THE WELDED PART, THE OUTER DIAMETER AND THE MFG RECORD OF THE SAME LOT. THE BASKET WAS DEFORMED. THEREFORE, OMSC CONSIDERS THAT THE CONDITIONS OF PT OR CALCULUS CAUSED THE FAILURE OF CRUSHING CALCULUS AND THE BREAKAGE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. PLEASE CROSS REFERENCE 8010047-2014-00291/00293/00294.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING CRUSHING CALCULUS IN THE BILE DUCT THE DOCTOR COULD NOT ROTATE THE KNOB OF BML HANDLE AND THE OPERATION PIPE OF THE SUBJECT DEVICE BROKEN. THE DOCTOR USED EMERGENCY HANDLE BML-110A-1 BUT FAILED AGAIN. HE WITHDREW THE BASKET WIRE FROM THE PT AND ABANDONED THE PROCEDURE. OMSC WAS INFORMED THAT THE PT REMAINED IN THE HOSPITAL AND SECOND PROCEDURE WAS SCHEDULED AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318330 OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V MECHANICAL LITHOTRIPTOR LQC OLYMPUS MEDICAL SYSTEMS CORPORATION BML-V437QR-30 K3Z14

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK