BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE DISTAL COVER

    MDR report key: 21416914 · Received February 19, 2025

    Report

    Report Number
    3003637092-2025-80000
    Event Type
    Malfunction
    Date Received
    February 19, 2025
    Date of Event
    September 12, 2024
    Report Date
    March 19, 2025
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT
    Product Code
    FDT
    PMA / PMN Number
    K220587
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO CORRECT D4 - UNIQUE IDENTIFIER (UDI) NUMBER. SINCE THE LOT NUMBER IS UNKNOWN AT THIS TIME, THE UDI IS EITHER (B)(4) DEPENDING ON THE LOT NUMBER USED.

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT IS RELATED TO MFR 9610595 - 2024 - 22164 (1/2).

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE DISTAL END COVER WAS USED WITHOUT BEING PROPERLY ATTACHED AND DROPPED OFF DUE TO THE LOAD DURING THE CASE. HOWEVER, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE REPORTED MALFUNCTION WAS NOT REPRODUCED AND A DEFINITIVE CAUSE WAS NOT IDENTIFIED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: - SECTION 8.2 "INSPECTION OF THE DISTAL COVER" ·SHOULD ANY IRREGULARITY BE OBSERVED WHEN INSPECTING THE DISTAL COVER, DO NOT USE IT. A DISTAL COVER WITH IRREGULARITY COULD NOT SERVE THE ENDOSCOPE PROPERLY AND/OR COULD FALL OFF DURING THE EXAMINATION. USING THE ENDOSCOPE WITHOUT THE DISTAL COVER COULD CAUSE PATIENT INJURY. ·CONFIRM THAT THE DISTAL COVER IS FREE FROM ANY IRREGULARITIES SUCH AS CRACKS, CHIPS, PINHOLES, OR DEFORMATION. SECTION -9.3 "ATTACHING THE DISTAL COVER" ·NEVER USE A DISTAL COVER WITH CRACKS OR PINHOLES. REPLACE IT WITH A NEW ONE. IF A DISTAL COVER WITH CRACKS OR PINHOLES IS USED, IT COULD FALL OFF DURING THE EXAMINATION AND/OR, IT MAY CAUSE THERMAL INJURY DUE TO ELECTRIC CURRENT LEAKS FROM CRACKS OR PINHOLES WHEN HIGH-FREQUENCY CAUTERIZATION TREATMENT IS PERFORMED. ALSO, USING THE DISTAL COVER WITH CRACKS MAY CAUSE PATIENT INJURY DUE TO SHARP EDGES. ·DO NOT APPLY ANTI-FOGGING PRODUCTS, OLIVE OIL, OR PRODUCTS CONTAINING PETROLEUM-BASED SUBSTANCES (E.G., VASELINE®) TO THE DISTAL COVER OR THE ENDOSCOPE. THESE PRODUCTS MAY CAUSE CRACKS IN THE DISTAL COVER. IF A DISTAL COVER WITH CRACKS IS USED, IT MAY CAUSE PATIENT INJURY SUCH AS: - THERMAL INJURY FROM ELECTRIC CURRENT LEAKS WHEN PERFORMING HIGH-FREQUENCY CAUTERIZATION TREATMENT. ·GENTLY HOLD THE DISTAL PART OF THE BENDING SECTION AND THE DISTAL COVER. ALIGN THE OPENING SIDE OF THE DISTAL COVER WITH THE LENS SIDE OF THE DISTAL END OF THE ENDOSCOPE. ·PUT YOUR FINGER ONTO THE CENTER ON THE TOP OF THE DISTAL COVER AND PUSH THE TOP OF THE DISTAL COVER STRAIGHT ONTO THE DISTAL END OF THE ENDOSCOPE UNTIL THE HOOK OF THE DISTAL RING IS COMPLETELY VISIBLE WITHIN THE OPENING OF THE DISTAL COVER. ·HOLD THE DISTAL PART OF THE BENDING SECTION. PULL THE DISTAL COVER GENTLY TO CONFIRM THAT THE DISTAL COVER ON THE DISTAL END OF THE ENDOSCOPE DOES NOT SLIP AND COME OFF. ·TWIST THE DISTAL COVER GENTLY IN BOTH DIRECTIONS AND CONFIRM THAT THE DISTAL COVER ON THE DISTAL END OF THE ENDOSCOPE DOES NOT SLIP AND COME OFF. ·CONFIRM THAT THE DISTAL COVER IS FREE OF CRACKS OR DEFORMATION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. THIS REPORT IS RELATED TO MFR 22164 (1/2).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SINGLE USE DISTAL COVER FELL OFF A SCOPE AT THE END OF A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). THE DOCTOR DID NOT SEE IT COME OFF AND DID NOT FIND IT. THERE WAS NO DELAY, AND THERE WAS NO PATIENT INJURY REPORTED. DUE TO THE NATURE OF THE DEVICE AND THE PROCEDURE, THE DISTAL CAP LIKELY FELL IN THE GASTROINTESTINAL TRACT AND CAN BE PASSED NATURALLY. IT IS ALSO ROUNDED AND SMOOTH WITH NO RISK FOR PERFORATION. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360067 SINGLE USE DISTAL COVER DISTAL COVER FDT OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT MAJ-2315 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DUODENOVIDEOSCOPE.