BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS VISERA CYSTO-NEPHRO VIDEOSCOPE

    MDR report key: 3044229 · Received April 1, 2013

    Report

    Report Number
    8010047-2013-00079
    Event Type
    Other
    Date Received
    April 1, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 5, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FAJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE AND THE MATERIAL WERE RETURNED TO OLYMPUS FOR EVAL. THE EVAL OF THE MATERIAL FOUND IT TO BE GLYCEROL, AND TO SEEM A LUBRICANT. ADDITIONALLY, THE EVAL OF THE DEVICE CONFIRMED A SLIGHT WHITE RESIDUE IN THE INSTRUMENT CHANNEL AND THE DISTAL END. AT THE PRESENT TIME, THE EXACT CAUSE OF THE REPORTED PHENOMENON CANNOT BE DETERMINED; HOWEVER, INSUFFICIENT REPROCESSING AND USER HANDLING CANNOT BE RULED OUT AS CONTRIBUTING FACTORS. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A CYSTOSCOPY PROCEDURE, THE PHYSICIAN NOTICED UNIDENTIFIED YELLOWISH MATERIAL IN THE PT'S BLADDER. THE PHYSICIAN RETRIEVED THE MATERIAL DURING THE PROCEDURE BY THE SUCTION WITH THE SAME DEVICE. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132140 OLYMPUS VISERA CYSTO-NEPHRO VIDEOSCOPE CYSTOSCOPE FAJ OLYMPUS MEDICAL SYSTEMS CORPORATION CYF-VA2

    Patients

    Seq Age Sex Outcome Treatment
    1