BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 20234527 · Received September 17, 2024

    Report

    Report Number
    9610877-2024-56864
    Event Type
    Malfunction
    Date Received
    September 17, 2024
    Date of Event
    September 2, 2024
    Report Date
    September 17, 2024
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    CAL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: THIS DEVICE IS NOT DISTRIBUTED IN US SO THAT 510K# IS BLANK. D4 UDI: "NOT DISTRIBUTED IN USA", BECAUSE PRODUCTS ARE NOT DISTRIBUTED IN USA PRODUCTS, BUT SIMILAR DEVICE PRODUCT ARE LISTED IN USA. THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE CFB (COHERENT FIBER BUNDLE) FLUID DAMAGE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE FLUID DAMAGE FROM THE CFB (COHERENT FIBER BUNDLE). IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE INSERTION FLEXIBLE TUBE FLUID DAMAGE, THE CONTROL BODY FLUID DAMAGE, THE FORWARD BODY FRAME FLUID DAMAGE, THE BIOPSY INLET T-PIECE FLUID DAMAGE, THE LIGHT SOURCE CONNECTOR FLUID DAMAGE, THE FORWARD BODY COVER BROKEN, THE U/D KNOB BROKEN, THE INSERTION FLEXIBLE TUBE PERFORATED, THE SEGMENT CRUSHED, AND THE ANGLE WIRE HARD TO MOVE; HOWEVER, THESE DEFECTS ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. THIS DEFECT OCCURRED NOT DURING PROCEDURE. BASED ON THE TECHNICAL REPORT ""HR-RPT-0586(IMAGE FAILURE)"" AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.

    Description of Event or Problem · 0

    THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(FLUID DAMAGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1901508 PENTAX FIBEROPTICINTUBATIONSCOPE 1.2C 3.0TP ROP CAL HOYA CORPORATION PENTAX TOKYO OFFICE FI-9RBS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown