BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS URETEROSCOPE

    MDR report key: 7124259 · Received December 15, 2017

    Report

    Report Number
    MW5074007
    Event Type
    Injury
    Date Received
    December 15, 2017
    Date of Event
    December 8, 2017
    Report Date
    December 14, 2017
    Manufacturer
    OLYMPUS
    Product Code
    FGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER A COMPLEX URETEROSCOPY WITH LASER LITHOTRIPSY, THE FLEXIBLE OLYMPUS URETEROSCOPE (ITEM #URF-P6R/ (B)(4)) WAS UNABLE TO BE REMOVED FROM THE PT BY THE UROLOGIST. THE UROLOGIST CUT THE SCOPE AND 18.5" OF IT STILL REMAINS IN THE PT. PT ADMITTED TO THE HOSPITAL TO AWAIT OCCURRENCE OF PASSIVE DILATION TO ENABLE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903214 OLYMPUS URETEROSCOPE OLYMPUS URETEROSCOPE FGB OLYMPUS P6R

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization