BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 19789944 · Received July 22, 2024

    Report

    Report Number
    9610877-2024-55589
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    July 10, 2024
    Report Date
    July 22, 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

    THIS DEVICE IS NOT DISTRIBUTED IN US SO THAT 510K# IS BLANK. 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 CONTROL BODY FLUID DAMAGE, THE FORWARD BODY FRAME FLUID DAMAGE, THE INSERTION FLEXIBLE TUBE COATING DAMAGE, THE FORWARD BODY COVER BROKEN, AND THE SIDE BODY COVER BROKEN; 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 AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED NOT 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
    2249455 PENTAX FIBEROPTICINTUBATIONSCOPE 1.4C 3.4TP ROP CAL HOYA CORPORATION PENTAX TOKYO OFFICE FHY-10RBS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown