BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHINO-LARYNGO FIBERSCOPE

    MDR report key: 19610628 · Received June 25, 2024

    Report

    Report Number
    3002808148-2024-05780
    Event Type
    Malfunction
    Date Received
    June 25, 2024
    Report Date
    July 29, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    EOB
    UDI-DI
    04953170059032
    PMA / PMN Number
    K011869
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER EIGHT (8) YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE MALFUNCTION WAS NOT CONFIRMED DURING EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. THREE ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED FROM THE CUSTOMER. THE EVENT CAN BE DETECTED AND/OR PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: IMPORTANT INFORMATION ¿ PLEASE READ BEFORE USE: ¿ DO NOT HIT TO THE DISTAL END OF THE INSERTION TUBE OR ALLOW IT TO STRIKE OTHER OBJECTS. THE OBJECTIVE LENS SURFACE OF THE DISTAL END IS PARTICULARLY FRAGILE, AND VISION ABNORMALITIES MAY RESULT. ¿ DO NOT TWIST OR BEND THE BENDING SECTION BY HANDS. EQUIPMENT DAMAGE MAY RESULT. ¿ DO NOT SQUEEZE THE BENDING SECTION FORCEFULLY. THE COVERING OF THE BENDING SECTION MAY STRETCH OR BREAK AND CAUSE WATER LEAKS. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT THERE WAS A MISSING SCREW FOR HOLD DOWN PLASTIC TIP WHEN USING THE FLEX VIDEO SCOPE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

    Description of Event or Problem · 0

    THE EVENT OCCURRED DURING REPROCESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481508 RHINO-LARYNGO FIBERSCOPE RHINO-LARYNGOFIBERSCOPE EOB SHIRAKAWA OLYMPUS CO., LTD. ENF-P4 04953170059032

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention