BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 13559876 · Received February 18, 2022

    Report

    Report Number
    9610877-2022-00317
    Event Type
    Malfunction
    Date Received
    February 18, 2022
    Report Date
    September 15, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOB
    PMA / PMN Number
    K921707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE ENDOSCOPE WILL BE EVALUATED BY PENTAX MEDICAL. ONCE EVALUATION IS COMPLETED THE DEVICE WILL BE REPAIRED AND RETURNED TO THE CUSTOMER OR LOANER INVENTORY AS APPLICABLE. MODEL FNL-15RP3, SERIAL NUMBER (B)(4) HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON 08-FEB-2022, A DEVICE HISTORY RECORD(DHR) REVIEW FOR MODEL FNL-15RP3, SERIAL NUMBER (B)(4) WAS PERFORMED BY THE MANUFACTURER. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED IN THE MIYAGI FACILITY ON 05-AUG-2012 UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO REWORKS OR CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED FOR 07-AUG-2012. THE INVESTIGATION IS IN-PROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Additional Manufacturer Narrative · 0

    DURING PENTAX INTERNAL REVIEW, THE SAME EVENT WAS FILED UNDER MDR (9610877-2022-50923) WHICH WAS SUBMITTED. THEREFORE, MDR (9610877-2022-00317) FILED ON FEBRUARY 18, 2022 IS CONSIDERED A DUPLICATE REPORT.

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT THAT OCCURRED IN THE UNITED STATES. THE CUSTOMER REPORTED POOR IMAGE QUALITY INVOLVING PENTAX MEDICAL FIBER NASO PHARYNGO LARYNGO SCOPE, MODEL FNL-15RP3, SERIAL NUMBER (B)(4). THE EVENT TIMING AND LOCATION ARE UNKNOWN. NO DEATH OR SERIOUS INJURY WAS REPORTED. 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
    17543 PENTAX FIBER NASO PHARYNGO LARYNGO SCOPE EOB HOYA CORPORATION PENTAX TOKYO OFFICE FNL-15RP3

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown