BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYSTO-NEPHRO VIDEOSCOPE

    MDR report key: 7344014 · Received March 15, 2018

    Report

    Report Number
    2951238-2018-00192
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    February 23, 2018
    Report Date
    March 1, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FAJ
    PMA / PMN Number
    PK062049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM NWB TO FAJ.

    Additional Manufacturer Narrative · 1

    THE CYSTOSCOPE AND THE BROKEN PORTION OF THE BENDING SECTION COVER GLUE WERE RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THAT PORTIONS OF THE BENDING SECTION COVER GLUE ON THE DISTAL END AND ON THE INSERTION SIDE WAS MISSING, THE REMAINING PORTION OF THE COVER GLUE WAS NOT DISCOLORED. THE BENDING SECTION COVER (DISTAL SHEATH) WAS CRACKED, PEELING, DISCOLORED, AND DENTED. THE INTERNAL CHANNEL OF THE CYSTOSCOPE WAS EXAMINED WITH THE USE OF A BORESCOPE AND THERE WAS NO SIGN OF MISSING PARTS OR FOREIGN OBJECT INSIDE THE CHANNEL OF THE DEVICE. THE CAUSE OF THE REPORTED INCIDENT CANNOT BE CONCLUSIVELY DETERMINED, BUT USER HANDLING CANNOT BE RULED OUT AS A CONTRIBUTORY FACTOR TO THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT A PORTION OF THE BENDING SECTION BROKE OFF AND FELL INTO THE PATIENT'S BLADDER. THREE SMALL BLACK PIECES WAS OBSERVED IN THE PATIENT'S BLADDER AS THE CYSTOSCOPE WAS BEING WITHDRAWN FROM THE PATIENT. THE THREE BLACK PIECES OF BENDING SECTION COVER GLUE WAS RETRIEVED FROM THE PATIENT BY AN UNKNOWN MEANS. THERE WAS NO REPORTED ADVERSE IMPACT TO THE PATIENT. THE PATIENT IS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183833 CYSTO-NEPHRO VIDEOSCOPE CYSTO-NEPHRO VIDEOSCOPE FAJ OLYMPUS MEDICAL SYSTEMS CORP. CYF-VH

    Patients

    Seq Age Sex Outcome Treatment
    1