BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 13091453 · Received December 28, 2021

    Report

    Report Number
    9610877-2021-51008
    Event Type
    Malfunction
    Date Received
    December 28, 2021
    Date of Event
    December 17, 2021
    Report Date
    December 28, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS NOT DISTRIBUTED IN US SO THAT 510K# IS BLANK. WE CHECKED THE RETURNED UNIT AND CONFIRMED THE CCD MODULE AS DEFECTIVE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE CCD MODULE. IN ADDITION, WE CONFIRMED THAT THE BENDING RUBBER LEAKAGE, THE INSERTION FLEXIBLE TUBE (IFT) BUCKLED, THE ROOT BRACE RUBBER CUT, AND THE REMOTE CONTROL BUTTONS CUT; HOWEVER, THEY ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT 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. VIDEO IMAGE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1990284 PENTAX RETROVIEW VIDEO COLONOSCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC-3490TFI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown