BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 12334847 · Received August 18, 2021

    Report

    Report Number
    9610877-2021-10139
    Event Type
    Injury
    Date Received
    August 18, 2021
    Date of Event
    January 1, 2021
    Report Date
    August 18, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    PMA / PMN Number
    K192245
    Removal / Correction Number
    Z-1682-2021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A USER FACILITY RESPONSE TO A GOOD FAITH EFFORT (GFE) WAS PROVIDED ON MAY 18 2021, AND FOLLOWING OCCURRED: 2 DEC CAPS DETACHED FROM THE SCOPE DURING PROCEDURE; 1 DETACHED IN THE PATIENTS MOUTH; 1 DETACHED IN THE PATIENTS STOMACH/ THIS CAP BROKE; THEY WERE ABLE TO RETRIEVE BOTH CAPS. THE CUSTOMER ORDERED A BOX OF KUMOE-A63 FOR 10 DISTAL CAPS. TWO OF THE CAPS FAILED DURING TWO SEPARATE PROCEDURES. BOTH CAPS WERE DISCARDED AND THE CUSTOMER IS RETURNING THE 8 REMAINING CAPS IN THAT ONE BOX. AFTER CHECKING THE RETURNED USED CAP, NO VISUAL DAMAGE OR DEFECTS WERE OBSERVED ON THE USED PIECE. RELATED MDR: 9610877-2021-10141. EVALUATION SUMMARY AS A RESULT OF THE INTERNAL INVESTIGATION, IT WAS DETERMINED THIS ISSUE WAS NOT RELATED TO DESIGN OR MANUFACTURING. IT WAS DETERMINED THAT IMPROVED TRAINING AND CLARIFICATION OF LABELING (IFUS) WOULD BE HELPFUL IN ENSURING PROPER ATTACHMENT AND CONTINUED SAFE USE OF THE DEVICE. AS A RESULT, PENTAX HAS UPDATED THE LABELING (BOTH THE DISTAL END CAP IFU AND THE DUODENOSCOPE IFU) FOR (B)(4). THE INSTRUCTIONS WERE UPDATED TO INCLUDE ADDITIONAL WORDING AND ILLUSTRATIONS TO HELP ENSURE A MORE SECURE ATTACHMENT OF THE DISTAL END CAP. IN ADDITION, THE WARNING SECTION OF THE IFUS HAVE BEEN UPDATED TO NOTIFY USERS OF THE ASSOCIATED RISKS WITH THE DISTAL END CAP (OE-A63) UNEXPECTEDLY BECOMING DETACHED DURING A PROCEDURE. THE UPDATE ALSO NOTIFIES USERS OF WHAT IMMEDIATE ACTIONS SHOULD BE TAKEN IN CASE THE EVENT OCCURS. THESE CHANGES WERE CLEARED IN 510(K) K210710 AND DISTRIBUTED TO THE INSTALLED BASE VIA A 21 CFR806.10 FIELD ACTION. IN ADDITION, A QUICK REFERENCE GUIDE UTILIZING EXISTING LABELING WAS CREATED, LAMINATED AND ATTACHED TO VIDEO PROCESSOR CARTS AT ALL US CUSTOMERS OF THE (B)(4). TRAINING TO THE QUICK REFERENCE GUIDE WAS COMPLETED AT ALL SITES, AND AN INSTRUCTIONAL VIDEO WAS PRODUCED AND HAS BEEN DISTRIBUTED TO ALL SITES. THEREFORE, PENTAX HAS INITIATED THIS CORRECTION TO PROVIDE THE LATEST IFU TO ALL US CUSTOMERS WITH THESE PENTAX DUODENOSCOPE DEVICES. THIS CORRECTION ACTIVITY ENSURES THAT ALL AFFECTED CUSTOMERS WILL RECEIVE THE DUODENOSCOPE INSTRUCTIONS FOR USE (IFU). CAPA NUMBER CAPA-(B)(4) WAS OPENED TO ADDRESS THIS ISSUE. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Description of Event or Problem · 1

    OE-A63 DEC CAPS DETACHED. THIS EVENT OCCURRED AT THE TIME OF DURING USE. DATE OF EVENT NOT KNOWN FOR THE EXACT DATE, WE JUST KNOW THE YEAR THE COMPLAINT WAS SENT IN TO MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234128 PENTAX SINGLE USE DISTAL END CAP WITH ELEVATOR FDT HOYA CORPORATION PENTAX TOKYO OFFICE OE-A63 0021100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other