BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 20342299 · Received October 1, 2024

    Report

    Report Number
    9610877-2024-00117
    Event Type
    Malfunction
    Date Received
    October 1, 2024
    Date of Event
    September 16, 2024
    Report Date
    December 5, 2024
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    MNL
    UDI-DI
    14961333221582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION B4: DATE OF THIS REPORT G6: FOLLOW UP #1 H2: IF FOLLOW-UP, WHAT TYPE? H3: DEVICE EVALUATED BY MANUFACTURE H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT ADDITIONAL INFORMATION D4: PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) # D9: IS THIS DEVICE AVAILABLE FOR EVALUATION? G4: DEVICE MANUFACTURE DATE. EVALUATION SUMMARY BESED ON THE INVESTIGATION HAS CONFIRMED THAT THE CUSTOMER ORDERED 2X CS5522A AND PENTAX MEDICAL CADANDA PROCESSED THE ORDER FOR 2X CS2022A. THE R&D DEPARTMENT OF PENTAX MEDICAL JAPAN CONDUCTED VALIDATION TEST OF REPROCESSING WITHOUT BRUSHING FOR I10C AND I20C SCOPES. THE RESULTS CONFIRMED THAT THERE WAS NO IMPACT ON REPROCESSING EVEN IF THE CUSTOMER USED THE WRONG BRUSH FOR REPROCESSING. A DEVICE HISTORY RECORD(DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED ON (B)(6) 2024 UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED. 9610877-2024-00116_CS2022A_0022404_INCORRECT BRUSHES. 9610877-2024-00118_CS2022A_0022404_INCORRECT BRUSHES. 9610877-2024-00119_CS2022A_0022404_INCORRECT BRUSHES. 9610877-2024-00120_CS2022A_0022404_INCORRECT BRUSHES.

    Additional Manufacturer Narrative · 0

    G4: THIS DEVICE IS NOT DISTRIBUTED IN THE USA, THEREFORE THE PMA/510(K) NUMBER IS NOT APPLICABLE. INVESTIGATION IS IN-PROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. 9610877-2024-00116 (B)(4) INCORRECT BRUSHES, (B)(4) INCORRECT BRUSHES, 9610877-2024-00118 (B)(4) INCORRECT BRUSHES, 9610877-2024-00119 (B)(4) INCORRECT BRUSHES, 9610877-2024-00120 (B)(4) INCORRECT BRUSHES.

    Description of Event or Problem · 0

    PER THE INITIAL REPORT, PENTAX INCORRECTLY PROCESSED AN ORDER (06-AUG-2024) FOR BRUSHES BY TRANSACTING BRUSH CS2022A LOT #0022404 INSTEAD OF CS5522A TWO BOXES. CUSTOMER RECEIVED AND USED 5 BRUSHES OUT OF 1 BOX OF 50 (RECEIVED 07-AUG-2024). CUSTOMER MENTIONED THEY DID NOT NOTICE RIGHT AWAY THAT IT WAS AN INCORRECT BRUSH. THE TWO BOXES WERE RETURNED INSIDE THE BOX FOR CS5522A, CONFIRMED BY CUSTOMER (B)(6) 2024. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915036 PENTAX PENTAX MEDICAL PROFILE SINGLE-USE CLEANING BRUSH MNL HOYA CORPORATION PENTAX TOKYO OFFICE CS2022A 0022404 14961333221582

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown