BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V

    MDR report key: 5437544 · Received February 15, 2016

    Report

    Report Number
    8010047-2016-00188
    Event Type
    Injury
    Date Received
    February 15, 2016
    Date of Event
    January 20, 2016
    Report Date
    June 16, 2016
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORP.
    Product Code
    LQC
    PMA / PMN Number
    K903529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION THAT OLYMPUS OBTAINED LATER IS SHOWN AND WAS CORRECTED. THE BASKET WIRE OF THIS EVENT WAS NOT SENT AND ONLY THE SHEATH WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR INVESTIGATION ON MAY 26, 2016. IT IS SURMISED THAT THE WIRE FRACTURED BECAUSE STRESS THAT EXCEEDED THE DURABILITY OF THE DEVICE WAS APPLIED TO CRUSH THE CALCULUS. A SIZE AND HARDNESS OF A CALCULUS ARE AMONG THE FACTORS THAT MAY CAUSE EXCESSIVE STRESS. DEFORMATION OF THE BASKET WAS MOST LIKELY CAUSED BY THE STRESS APPLIED UPON CRUSHING THE CALCULUS.

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE MANUFACTURING HISTORY OF THE SUBJECT DEVICE WAS REVIEWED, WITH NO IRREGULARITIES NOTED. THEREFORE THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION OR THE DEVICE IS RECEIVED A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    LITHOTRIPTOR OVER WIRE BASKET FAILED TO CRUSH DUCAL STONE AND IN THE PROCESS BROKE INSIDE THE DUCT. WHEN DEVICE WAS REMOVED FROM PATIENT NOT ALL COMPONENTS CAME OUT LEAVING BASKET, STONE IN DUCT AND 3 UNCOVERED WIRES PROTRUDING. PATIENT WAS TRANSFERRED TO THEATRE FOR OPEN SURGERY TO REMOVE THIS SUBJECT DEVICE(I.E. BASKET AND 3 WIRES) AND LARGE STONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94707 OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V MECHANICAL LITHOTRIPTOR LQC OLYMPUS MEDICAL SYSTEM CORP. BML-V442QR-30 58K

    Patients

    Seq Age Sex Outcome Treatment
    1 Other