BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE DISTAL COVER

    MDR report key: 20137721 · Received September 4, 2024

    Report

    Report Number
    3003637092-2024-00144
    Event Type
    Injury
    Date Received
    September 4, 2024
    Date of Event
    August 12, 2024
    Report Date
    January 29, 2025
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT
    Product Code
    FDT
    UDI-DI
    04953170441271
    PMA / PMN Number
    K220587
    Removal / Correction Number
    Z-1071-2024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER AS REFLECTED IN B5. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-0000405-1.

    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 HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER (B)(4). THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIER: (B)(6).

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. UPDATES ARE ADDED TO THE FOLLOWING FIELDS: H4, H6, H7, H9, AND H11. 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, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THE REPORTED EVENT WAS PRESUMED TO HAVE BEEN DUE TO THE DISTAL END COVER BEING USED WITHOUT BEING PROPERLY ATTACHED AND DROPPED OFF DUE TO THE LOAD DURING THE CASE. SINCE IT IS DIFFICULT TO VISUALLY DETECT THE STATE OF ATTACHMENT OF THIS PRODUCT, IT IS FEASIBLE THAT THE DESCRIPTION IN THE PREVIOUS INSTRUCTIONS FOR USE (IFU) WAS INSUFFICIENT. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE IFU WHICH STATE: [IFU AT TIME OF OCCURRENCE] - 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. [LATEST IFU] DETAILED INSTRUCTIONS AND NOTES ON HOW TO INSPECT AND ATTACH THE DISTAL COVER HAVE BEEN ADDED TO SECTIONS 9.3 AND 9.4 OF THE IFU. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    UPDATED D4 TO (B)(4).

    Description of Event or Problem · 0

    IT WAS ADDITIONALLY REPORTED THAT THE ISSUE OCCURRED IN THE MIDDLE OF AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE PROCEDURE WAS DELAYED FOR AN UNSPECIFIED TIME TO RETRIEVE THE COVER AND WAS THEN COMPLETED WITH A NEW DISTAL COVER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DISTAL COVER FELL OFF FROM THE DUODENOVIDEOSCOPE AND INTO THE PATIENT. THE CUSTOMER RETRIEVED THE DISTAL COVER SUCCESSFULLY WITHOUT ANY ISSUES. THERE WERE NO REPORTS OF PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED BUT NO FURTHER INFORMATION WAS OBTAINED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369139 SINGLE USE DISTAL COVER DISTAL COVER FDT OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT MAJ-2315 H3X12 04953170441271

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention