BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 14868620 · Received June 30, 2022

    Report

    Report Number
    9610877-2022-00515
    Event Type
    Malfunction
    Date Received
    June 30, 2022
    Date of Event
    June 7, 2022
    Report Date
    September 7, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    GCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 DISTRIBUTED IN US SO THAT UNIQUE IDENTIFIER IS BLANK. THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE.

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION: G6: FOLLOW UP #1. H2:IF FOLLOW-UP, WHAT TYPE? H3:DEVICE EVALUATED BY MANUFACTURE. H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT. EVALUATION SUMMARY: IT IS PRESUMED THAT THE PHENOMENON WAS CAUSED BY THE BLURRING OF THE IMAGE DUE TO DIRT ON THE LENS SURFACE. REGARDING THIS PHENOMENON, WE HAVE DETERMINED THAT IT MAY BE DIFFICULT TO REMOVE DIRT FROM THE LENS DUE TO ENVIRONMENTAL FACTORS.

    Description of Event or Problem · 0

    CUSTOMER REPORTED BLURRY PICTURE AND THERE WAS A BIG WHITE SPOT ON THE LENS. THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960100 PENTAX ENDOSCOPE GCQ HOYA CORPORATION PENTAX TOKYO OFFICE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown