BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS VISERA CYSTO-NEPHRO VIDEOSCOPE

    MDR report key: 2543101 · Received April 10, 2012

    Report

    Report Number
    8010047-2012-00116
    Event Type
    Other
    Date Received
    April 10, 2012
    Report Date
    March 12, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORP
    Product Code
    FAJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY VIA PHONE AND IN WRITING TO OBTAIN ADDITIONAL DETAILED INFORMATION REGARDING THIS REPORT, BUT RECEIVED ONLY LIMITED INFORMATION. THE REPORTING PHYSICIAN INDICATED THAT HE BELIEVED THE INFECTION HAD OCCURRED FOLLOWING AN OFFICE CYSTOSCOPY. A GYRUS/ACMI CLINICAL NURSE SPECIALIST VISITED THE USER FACILITY, AND REVIEWED THE USER FACILITY'S REPROCESSING METHODS, AND NOTED THAT THE USERS WERE NOT REPROCESSING THE DEVICE IN ACCORDANCE WITH THE DIRECTIONS FOR USE. THE USER FACILITY WAS SAID NOT TO BE PERFORMING ANY LEAK TESTING OR MANUAL CLEANING OF THE SUBJECT DEVICE PRIOR TO SOAKING IT IN A HIGH-LEVEL DISINFECTANT. THE CLINICAL NURSE SPECIALIST PROVIDED IN-SERVICE TRAINING TO THE USER FACILITY PERSONNEL. OLYMPUS WAS INFORMED THAT THE PT WAS CULTURED THREE TIMES AND ALL OF THE RESULTS RETURNED NEGATIVE. THE DEVICE REFERENCE IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. BASED UPON THE INFORMATION PROVIDED, THIS EVENT APPEARS TO BE DUE TO USER ERROR. 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 ONE PT HAD ACQUIRED A PSEUDOMONAS INFECTION FOLLOWING A DIAGNOSTIC CYSTOSCOPY PROCEDURE USING THE SUBJECT DEVICE. THERE WAS NO INFORMATION PROVIDED REGARDING WHAT, IF ANY TREATMENT HAD BEEN PROVIDED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS VISERA CYSTO-NEPHRO VIDEOSCOPE CYSTOSCOPE FAJ OLYMPUS MEDICAL SYSTEM CORP CYF-V2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1