BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12595420 · Received October 7, 2021

    Report

    Report Number
    9610877-2021-01198
    Event Type
    Malfunction
    Date Received
    October 7, 2021
    Date of Event
    September 17, 2021
    Report Date
    December 24, 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

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. THIS DEVICE IS NOT MARKETED IN US, THEREFORE 510K IS NOT APPLICABLE.

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: THIS DEVICE IS NOT DISTRIBUTED IN US SO THAT 510K# IS BLANK. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE OPERATION CHANNEL BUCKLED, INSERTION FLEXIBLE TUBE (IFT) LOOSENED. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE OPERATION CHANNEL BUCKLED; HOWEVER, OTHER FAILURES ARE NOT RELATED TO THE ALLEGED COMPLAINT. CORRECTION INFORMATION: FOLLOW UP #1, CODING CHANGED BASED ON THE INVESTIGATION RESULT.

    Description of Event or Problem · 0

    THE OP-CHANNEL IS DEFECTIVE. THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1485332 PENTAX VIDEO COLONO SCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC-380MK2P

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown