BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE DISTAL COVER

    MDR report key: 19534112 · Received June 13, 2024

    Report

    Report Number
    3003637092-2024-00105
    Event Type
    Injury
    Date Received
    June 13, 2024
    Date of Event
    June 5, 2024
    Report Date
    October 14, 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
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND TO PROVIDE A CORRECTION TO FIELDS (A2, A3, A4, B5, E2, E3, AND G2). ADDITIONALLY, TO PROVIDE AN UPDATE TO 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 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 INADVERTENTLY LEFT OUT: IT WAS REPORTED THAT NO ANTI-FOG AGENT WAS USED FOR THE PROCEDURE. THE USER PULLED OR TWISTED THE DISTAL COVER DURING INSPECTION PRIOR TO USE TO MAKE SURE IT DOES NOT COME OFF ENDOSCOPE. THE USER CONFIRMED DURING INSPECTION PRIOR TO USE THAT PROXIMAL END OF THE DISTAL COVER COMPLETELY OVERCOMES HOOK OF THE ENDOSCOPE. ADDITIONALLY, THE USER USED BOSTON SCIENTIFIC ENDOGLIDE STERILE BACTERIOSTATIC LUBRICATING GEL. THE CAP WAS VERIFIED TO BE IN PLACE AND INTACT PRIOR TO THE PROCEDURE BY THE TECH AND MEDICAL DOCTOR. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    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 THE FOLLOWING LINKED PATIENT IDENTIFIER: ¿ (B)(6).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION INADVERTENTLY LEFT OUT: IT WAS REPORTED THAT THE PROCEDURE WENT LONGER THAN EXPECTED TO RETRIEVE THE DISTAL COVER. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND THE DELAY WAS 10-15 MINUTES. THE INTENDED PROCEDURE WAS COMPLETED. THE DEVICE MALFUNCTION OCCURRED TOWARDS THE END OF THE PROCEDURE, AFTER THE METAL BILIARY STENT WAS PLACED. FURTHERMORE, THE CUSTOMER STATED THEY HAVE DEVELOPED A PROCESS TO ENSURE THE CAP IS INSTALLED CORRECTLY AND DONE IN-SERVICE. THE SURGICAL ASSISTANT CHECKS DISTAL COVER FOR PLACEMENT AND ENDOSCOPIST CHECKS THE CAP FOR ADEQUATE PLACEMENT PRIOR TO INSERTION INTO PATIENT. THE CAP WAS ATTACHED CORRECTLY, THE CRACK MAY HAVE CAUSED THE DISLODGED PLACEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CASE, THE DISTAL COVER BECAME DISLODGED INTO PATIENT¿S DUODENUM. A STENT WAS DEPLOYED, AND DISTAL COVER LOCATED. THE DEVICE WAS PULLED OUT INTO THE DUODENUM WITH THE AID OF BIOPSY FORCEPS INTO THE STOMACH. A SNARE WAS THEN USED, AND DEVICE REMOVED FROM THE PATIENT¿S MOUTH. THE COVER WAS CRACKED. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153414 SINGLE USE DISTAL COVER DISTAL COVER FDT OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT MAJ-2315 H362B 04953170441271

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention DUODENOVIDEOSCOPE, TJF-Q190V, (B)(6).