BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS VISERA CYSTO-NEPHRO VIDEOSCOPE

    MDR report key: 3031153 · Received March 4, 2013

    Report

    Report Number
    8010047-2013-00071
    Event Type
    Malfunction
    Date Received
    March 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORP
    Product Code
    FAJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY VIA PHONE AND IN WRITING TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORT WITHOUT SUCCESS. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THE USER'S REPORT. THE BENDING SECTION COVER WAS TORN AND STRETCHED. THE BENDING SECTION COVER GLUE WAS CRACKED AT BOTH ENDS LIKELY DUE TO CHEMICAL DAMAGE. THERE WERE NICKS AND SCRATCHES NOTED ON THE INSERTION TUBE UNIT AND INDENTATION BELOW THE PROTECTOR BOOT. THE INSTRUMENT CHANNEL WAS INSPECTED WITH NO SCRAPE OR TEAR MARKS OBSERVED. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED. THE REFERENCED DEVICE WILL BE SERVICED AND RETURN TO THE CUSTOMER.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE BENDING SECTION COVER WAS TORN, AND THE ANGULATION WAS OUT OF SPECIFICATION. THE PT REPORTEDLY SUSTAINED AN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92553 OLYMPUS VISERA CYSTO-NEPHRO VIDEOSCOPE CYSTOSCOPE FAJ OLYMPUS MEDICAL SYSTEM CORP CYF-V2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK