BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE DISTAL COVER

    MDR report key: 20146510 · Received September 5, 2024

    Report

    Report Number
    3003637092-2024-00145
    Event Type
    Injury
    Date Received
    September 5, 2024
    Date of Event
    August 8, 2024
    Report Date
    October 18, 2024
    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
    WI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS RELATED TO THE FOLLOWING PATIENT IDENTIFIERS (B)(6). THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-0000402. THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. ADDITIONALLY, TO PROVIDE AN UPDATE WITH INFORMATION RECEIVED, TO PROVIDE A CORRECTION TO FIELD (G2), AND TO PROVIDE AN UPDATE FIELDS (H4, H7, AND H9). 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, IT IS LIKELY THAT THE REPORTED EVENT OCCURRED DUE TO THE DISTAL END COVER WAS USED WITHOUT BEING PROPERLY ATTACHED AND DROPPED OFF DUE TO THE LOAD DURING THE CASE. ADDITIONALLY, IT IS DIFFICULT TO VISUALLY DETECT THE STATE OF ATTACHMENT OF THIS PRODUCT, IT IS FEASIBLE THAT THE DESCRIPTION IN THE PREVIOUS INSTRUCTION FOR USE (IFU) WAS INSUFFICIENT. HOWEVER, THE SUBJECT DEVICE WAS NOT RETURNED, AND THE ROOT CAUSE OF THE SUGGESTED EVENT COULD NOT BE DETERMINED. 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. (REVISED 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 INSTRUCTIONS FOR USE. " ADDITIONAL INFORMATION RECEIVED: THE CUSTOMER CONFIRMED THAT NO ANTI-FOG AGENT WAS USED. AFTER ATTACHING THE DISTAL COVER TO THE ENDOSCOPE, THE USER CONFIRMED THAT THE DISTAL COVER WAS NOT DAMAGED AND THE USER CONFIRMED THAT THE DISTAL COVER COULD NOT BE REMOVED FROM THE ENDOSCOPE BY PULLING OR TWISTING IT. THE USER CONFIRMED THAT THE DISTAL COVER WAS PUSHED IN FIRMLY UNTIL THE HOOK OF THE ENDOSCOPE WAS COMPLETELY VISIBLE THROUGH THE OPENING OF THE DISTAL COVER. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE CORRECTION WITH INFORMATION INADVERTENTLY LEFT OUT (H6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE DISTAL END CAP FELL OFF INTO THE PATIENT'S BODY. THE DEVICE APPEARED TO HAVE FALLEN OFF DURING THE WITHDRAWAL OF THE SCOPE AFTER THE PROCEDURE WAS COMPLETED, SO THERE WAS NO NEED TO REPLACE IT. THERE WAS AN ATTEMPT TO LOCATE THE FALLEN CAP WITH ANOTHER SCOPE WHICH PROLONGED THE PROCEDURE BY AN UNSPECIFIED AMOUNT OF TIME. UPON INSPECTION AFTER REMOVAL, THE CAP WAS FULLY INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1913121 SINGLE USE DISTAL COVER DISTAL COVER FDT OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT MAJ-2315 H3Y28 04953170441271

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention TJF-Q190VSERIAL NUMBER (B)(6)