BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA BRONCHOVIDEOSCOPE

    MDR report key: 16461991 · Received March 1, 2023

    Report

    Report Number
    9610595-2023-03509
    Event Type
    Malfunction
    Date Received
    March 1, 2023
    Report Date
    May 18, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    PMA / PMN Number
    K023984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON 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. BASED ON THE RESULTS OF THE INVESTIGATION, THE DEFINITIVE ROOT CAUSE OF THE PEELED COATING COULD NOT BE DETERMINED. THE PEELED COATING MAY HAVE BEEN CAUSED BY STRESS OF REPEATED USE, EXTERNAL FACTORS, OR HANDLING OF THE DEVICE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RECEIVED AND EVALUATED . DEVICE EVALUATION FOUND CUT ON CONNECTING TUBE, DUE TO THE CUT, WATERTIGHTNESS IS LOST, (LEAKAGE) WAS OBSERVED. IN ADDITION, INSPECTION FOUND DENT ON S-COVER (SCOPE COVER) (CONTROL SECTION) DUE TO DENT, WATERTIGHTNESS IS LOST THE REPORTED ISSUE OF LEAKAGE WAS CONFIRMED. FURTHERMORE, DEVICE EVALUATION FOUND THE COATING OF THE DEVICE INSERTION SECTION (BENDING MANIPULATION) WAS PEELING WHICH IS GREATER THAN OR EQUAL TO 1X1 MM2. THIS CONDITION WAS ATTRIBUTED DUE TO DETERIORATION AND OR HANDLING ISSUE. ADDITIONALLY, THE FOLLOWING DEFECTS WERE IDENTIFIED DURING DEVICE INSPECTION: ADHESIVE ON A-RUBBER (ADHESIVE CONNECTION) HAS A CHIP. IMAGE GUIDE (IG) PROTECTOR HAS A CUT. ANGULATION LEVER HAS A CRACK. DUE TO WEAR OF ANGLE WIRE, BENDING ANGLE IN UP DIRECTION DOES NOT MEET THE STANDARD VALUE. AN ABNORMAL SOUND IS MADE DUE TO DAMAGE ON ANGULATION LEVER. CONNECTING TUBE HAS A DENT. EL-CONNECTOR HAS CORROSION DUE TO WATER LEAKAGE. SCRATCH FOUND ON UP/DOWN , UNIVERSAL CORD , GRIP , SCOPE CONNECTOR. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Description of Event or Problem · 0

    COMPANY REPRESENTATIVE SENT A REPAIR REQUEST REPORTED WITH AN ISSUE OF 'LEAKAGE". NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED. DEVICE EVALUATION FOUND THE COATING OF THE DEVICE INSERTION SECTION (BENDING MANIPULATION) WAS FOUND TO BE PEELING WHICH IS GREATER THAN OR EQUAL TO 1X1 MM2. THIS REPORT IS BEING SUBMITTED DUE TO THE FINDING OF COATING OF THE DEVICE INSERTION SECTION (BENDING MANIPULATION) PEELING OFF (GREATER THAN OR EQUAL TO 1 X 1 MM2, MARKING DISAPPEARANCE, DETERIORATION) IDENTIFIED DURING DEVICE RETURN EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148578 EVIS LUCERA BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-260

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown