BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS SINGLE USE MECHNICAL LITHOTRIPTOR V

    MDR report key: 3770271 · Received March 7, 2014

    Report

    Report Number
    8010047-2014-00090
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    February 13, 2014
    Report Date
    February 13, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    LQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC FOR INVESTIGATION SINCE THE DEVICE WAS DISCARDED BY THE FACILITY. THE EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINED. THE DOCTOR REPORTED THAT THIS EVENT OCCURRED DUE TO HARD CALCULUS. THEREFORE, OMSC CONSIDERS THAT IT WAS TOO HARD TO CRUSH THE CALCULUS. THE DEVICE INSTRUCTION MANUAL HAS WARNED USERS THAT THERE IS POSSIBILITY THE CALCULI CANNOT BE CRUSHED BY LITHOTRIPTOR, AND IT ALSO DESCRIBES WHAT TO DO IF THE LITHOTRIPTOR CANNOT CRUSH THE CALCULUS. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT DURING CRUSHING CALCULUS IN THE COMMON BILE DUCT, THE SUBJECT DEVICE WAS STUCK IN THE PT. OMSC SALES REP BROUGHT BMI-110A-1 TO THE FACILITY AND THE DOCTOR CRUSHED CALCULUS WITH IT. IN ADDITION, HE PERFORMED ENDOSCOPIC SPHINCTEROTOMY (EST) AGAIN AND RETRIEVED CRUSHED CALCULI USING BALLOON. THE DOCTOR COMPLETED THE PROCEDURE AS FEW CALCULI REMAINED IN THE PT. THERE WAS NO PT REGARDING OF PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139562 OLYMPUS SINGLE USE MECHNICAL LITHOTRIPTOR V MECHANICAL LITHOTRIPTOR LQC OLYMPUS MEDICAL SYSTEMS CORP. BMI-V437QR-30 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1