BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA CYSTO-NEPHRO VIDEOSCOPE

    MDR report key: 6840454 · Received September 1, 2017

    Report

    Report Number
    2951238-2017-00580
    Event Type
    Malfunction
    Date Received
    September 1, 2017
    Date of Event
    May 5, 2017
    Report Date
    March 1, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FAJ
    PMA / PMN Number
    K133538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. SINCE NO SERIAL NUMBER AND USER FACILITY INFORMATION WAS PROVIDED, OLYMPUS WAS UNABLE TO PERFORM AN INSTRUMENT SERVICE HISTORY REVIEW. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM NWB TO FAJ AND 510(K) NUMBER.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A MEDWATCH REPORT (MW5071244) ON (B)(6) 2017 STATING THAT DURING A CYSTOSCOPY PROCEDURE, AN UNKNOWN SUBSTANCE COMING FROM THE SCOPE WAS FOUND INSIDE THE PATIENT¿S BLADDER. THE PATIENT¿S BLADDER WAS DRAINED AND THERE APPEARED TO BE AN ¿OIL EMULSION¿ FLOATING IN THE URINE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618918 VISERA CYSTO-NEPHRO VIDEOSCOPE CYSTO-NEPHRO VIDEOSCOPE FAJ OLYMPUS MEDICAL SYSTEMS CORP. CYF-V2R N/A

    Patients

    Seq Age Sex Outcome Treatment
    1