BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 19698877 · Received July 9, 2024

    Report

    Report Number
    9610877-2024-55165
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    June 27, 2024
    Report Date
    July 9, 2024
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    CAL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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) BROKEN. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE CFB (COHERENT FIBER BUNDLE). IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE INSERTION FLEXIBLE TUBE BUCKLED, AND THE INSERTION FLEXIBLE TUBE CRUSHED; HOWEVER, THESE DEFECTS ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. 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 UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE (BROKEN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257021 PENTAX FIBEROPTICINTUBATIONSCOPE 2.4TP RO PLS CAL HOYA CORPORATION PENTAX TOKYO OFFICE FP-7RBS2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown