BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA CYSTO-NEPHRO VIDEOSCOPE

    MDR report key: 6347918 · Received February 21, 2017

    Report

    Report Number
    2951238-2017-00103
    Event Type
    Malfunction
    Date Received
    February 21, 2017
    Report Date
    February 27, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FAJ
    PMA / PMN Number
    K133538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THE REPORTED DEVICE DAMAGE. THE BENDING SECTION RUBBER GLUE WAS FOUND CRACKED, EXPOSING THE WIRE THREADS. IN ADDITION, MINOR CRACKS ON THE DISTAL END COVER INSULATION GLUE WERE NOTED. THE DEVICE WAS SERVICED AND RETURNED TO THE USER FACILITY. BASED ON THE INVESTIGATION FINDINGS, THE CAUSE OF THE REPORTED EVENT IS MOST LIKELY DUE TO THE OPERATOR¿S TECHNIQUE/HANDLING OF THE DEVICE. THE INSTRUCTION MANUAL FOR USE STATES, ¿THE PROBABILITY OF FAILURE OF THE ENDOSCOPE AND ANCILLARY EQUIPMENT INCREASES AS THE NUMBER OF PROCEDURES PERFORMED AND/OR THE TOTAL OPERATING HOURS INCREASE. IN ADDITION TO THE INSPECTION BEFORE EACH PROCEDURE, THE PERSON IN CHARGE OF MEDICAL EQUIPMENT MAINTENANCE IN EACH FACILITY SHOULD INSPECT THE ITEMS SPECIFIED IN THIS MANUAL PERIODICALLY. AN ENDOSCOPE WITH AN OBSERVED IRREGULARITY SHOULD NOT BE USED. DO NOT STRIKE, BEND, HIT, PULL, TWIST, OR DROP THE ENDOSCOPE¿S DISTAL END, INSERTION TUBE, BENDING SECTION, AND CONTROL SECTION WITH EXCESSIVE FORCE. THE ENDOSCOPE MAY BE DAMAGED AND COULD CAUSE PATIENT INJURY, SUCH AS BURNS, BLEEDING, AND/OR PERFORATION. IT COULD ALSO CAUSE PARTS OF THE ENDOSCOPE TO FALL OFF INSIDE THE PATIENT. DO NOT APPLY SHOCK TO THE DISTAL END OF THE INSERTION TUBE, PARTICULARLY THE OBJECTIVE LENS SURFACE AT THE DISTAL END. VISUAL ABNORMALITIES MAY RESULT.¿ AS PART OF OUR INVESTIGATION, OLYMPUS MADE MULTIPLE FOLLOW UPS WITH THE USER FACILITY BY TELEPHONE AND IN WRITING IN AN ATTEMPT TO GATHER ADDITIONAL INFORMATION ON THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS OBTAINED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE DEVICE WAS NOTED WITH A SHARP EDGE ON THE DISTAL TIP. IT IS UNKNOWN IF THE DEVICE DAMAGE OCCURRED DURING A PROCEDURE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129563 VISERA CYSTO-NEPHRO VIDEOSCOPE CYSTO-NEPHRO VIDEOSCOPE FAJ OLYMPUS MEDICAL SYSTEMS CORP. CYF-V2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1