BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHINO-LARYNGO VIDEOSCOPE

    MDR report key: 19234334 · Received May 2, 2024

    Report

    Report Number
    3002808148-2024-04098
    Event Type
    Malfunction
    Date Received
    May 2, 2024
    Report Date
    May 24, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    EOB
    UDI-DI
    04953170434693
    PMA / PMN Number
    K221638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    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 8 YEARS, SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE EVENT CAN BE [DETECTED/PREVENTED] ,BY FOLLOWING THE INSTRUCTIONS FOR USE: INSTRUCTIONS OPERATION MANUAL RHINO-LARYNGO VIDEOSCOPE, OLYMPUS ENF-V3/OLYMPUS ENF-VH IMPORTANT INFORMATION. PLEASE READ BEFORE USE. PRECAUTIONS: DO NOT STRIKE, HIT OR DROP THE DISTAL END, INSERTION TUBE, BENDING SECTION, CONTROL SECTION, UNIVERSAL CORD, VIDEO CONNECTOR OR LIGHT GUIDE CONNECTOR OF THE ENDOSCOPE. ALSO, DO NOT BEND, PULL OR TWIST THE DISTAL END, INSERTION TUBE, BENDING SECTION, CONTROL SECTION, UNIVERSAL CORD, VIDEO CONNECTOR OR LIGHT GUIDE CONNECTOR OF THE ENDOSCOPE WITH EXCESSIVE FORCE. THE ENDOSCOPE MAY BE DAMAGED AND COULD CAUSE PATIENT INJURY, BURNS, BLEEDING AND/OR PERFORATIONS. IT COULD ALSO CAUSE, PARTS OF THE ENDOSCOPE TO FALL OFF INSIDE THE PATIENT. DO NOT ATTEMPT TO BEND OR TWIST THE ENDOSCOPE¿S INSERTION SECTION WITH EXCESSIVE FORCE. THE INSERTION SECTION MAY BE DAMAGED. DO NOT APPLY SHOCK TO THE DISTAL END OF THE ENDOSCOPE, IN PARTICULAR THE OBJECTIVE LENS SURFACE AT THE DISTAL END OF THE ENDOSCOPE. AN ABNORMAL ENDOSCOPIC IMAGE MAY RESULT. DO NOT TWIST OR BEND THE BENDING SECTION WITH YOUR 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE RHINO-LARYNGO VIDEOSCOPE EXHIBITED A LIGHT GUIDE LENS THAT WAS DISLODGED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457365 RHINO-LARYNGO VIDEOSCOPE RHINO-LARYNGO VIDEOSCOPE EOB SHIRAKAWA OLYMPUS CO., LTD. ENF-VH 04953170434693

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown