BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACHEAL INTUBATION FIBERSCOPE

    MDR report key: 17209650 · Received June 27, 2023

    Report

    Report Number
    9610595-2023-09345
    Event Type
    Malfunction
    Date Received
    June 27, 2023
    Report Date
    June 27, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    UDI-DI
    04953170340192
    PMA / PMN Number
    K981543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION OF THE RETURNED THE DEVICE CONFIRMED THE CUSTOMER ALLEGATION. THE FOLLOWING ISSUES WERE FOUND DURING THE DEVICE EVALUATION: (A.) DUE TO A PINHOLE ON THE CHANNEL TUBE, WATER TIGHTNESS IS LOST, (B.) DUE TO A PINHOLE ON THE BENDING SECTION COVER, WATER TIGHTNESS IS LOST, (C.) DUE TO DEFORMATION OF THE CONTROL UNIT, WATER TIGHTNESS IS LOST, (D.) ADHESIVE ON THE BENDING SECTION COVER DISTAL END HAD A CHIP, (E.) DUE TO THE WEAR OF ANGLE WIRE, BENDING ANGLE IN THE UP DIRECTION DOES NOT MEET THE STANDARD VALUE, (F.) DUE TO DAMAGE ON THE CHANNEL TUBE, THE CHANNEL CLEANING BRUSH CANNOT INSERT SMOOTHLY, (G.) THE LIGHT GUIDE BUNDLE HAD BREAKAGE, (H.) THE BENDING TUBE WAS DAMAGED, (I.) SCRATCHES WERE FOUND ON MULTIPLE PARTS (J.) THE EYEPIECE HAD DAMAGE, (K.) THE CONNECTING TUBE HAD A DENT, (L.) THE CONTROL UNIT IS DEFORMED, (M) THE VENTING CONNECTOR UNDER GRIP IS SHAVED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE - "PEELING OF THE COATING OF THE IMAGE GUIDE TUBE". BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE COATING OF THE IMAGE GUIDE TUBE WAS PEELED OFF BY STRESS OF REPEATED USE, EXTERNAL FACTORS, OR HANDLING. THE ROOT CAUSE OF THIS EVENT WAS UNABLE TO BE IDENTIFIED. THE USER IS ADVISED TO READ INSTRUCTIONS FOR USE (IFU) MANUAL AND HANDLE THE DEVICE IN ACCORDANCE WITH IFU TO PREVENT RECURRENCE OF THE SUGGESTED EVENT. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE COMPANY REPRESENTATIVE ON BEHALF OF THE CUSTOMER REPORTED TO OLYMPUS THAT THE TRACHEAL INTUBATION FIBERSCOPE EXHIBITED AIR LEAK. DURING INSPECTION, IT WAS FOUND THAT THE COATING OF THE IMAGE GUIDE TUBE WAS PEELED OFF (ONE MILLIMETER SQUARE OR MORE). THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT. THIS REPORT IS BEING SUBMITTED FOR THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930679 TRACHEAL INTUBATION FIBERSCOPE TRACHEAL INTUBATION FIBERSCOPE EOQ AIZU OLYMPUS CO., LTD. LF-DP 04953170340192

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown