BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS SINGL USE MECHANICAL LITHOTRIPTOR V

    MDR report key: 3934877 · Received June 20, 2014

    Report

    Report Number
    2951238-2014-00239
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 2, 2014
    Manufacturer
    OLYMPUS AMERICA, INC.
    Product Code
    FEO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. HOWEVER, BASED ON THE INFORMATION PROVIDED, THE REPORTED PHENOMENON APPEARS TO BE DUE TO USER ERROR, AS THE DEVICE WAS USED OFF-LABEL. THE BML-V442QR INSTRUCTION MANUAL INTENDED USE SECTION STATES: "THIS INSTRUMENT HAS BEEN DESIGNED TO BE USED WITH AN OLYMPUS ENDOSCOPE FOR CRUSHING CALCULI INSIDE THE BILE DUCT. DO NOT USE THIS INSTRUMENT FOR ANY PURPOSE OTHER THAN ITS INTENDED USE". IF ADDITIONAL INFORMATION OR IF THE DEVICE IS RECEIVED AT A LATER TIME THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A BILIARY TRACT PROCEDURE, THE USER ATTEMPTED TO RETRIEVE A NON-OLYMPUS BALLOON INSIDE THE PATIENT; HOWEVER, THE DEVICE FAILED TO RETRIEVE THE BALLOON. THE PATIENT WAS REPORTED TO HAVE UNDERGONE AN OPEN SURGERY TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364264 OLYMPUS SINGL USE MECHANICAL LITHOTRIPTOR V MECHANICAL LILTHOTRIPTOR FEO OLYMPUS AMERICA, INC. BML--442QR-30 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention