BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 13015051 · Received December 15, 2021

    Report

    Report Number
    9610877-2021-01832
    Event Type
    Malfunction
    Date Received
    December 15, 2021
    Date of Event
    December 6, 2021
    Report Date
    March 10, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    UDI-DI
    04961333237586
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EG29-I10C-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K190805.

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EG29-I10C-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K190805. 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. BASED ON THE TECHNICAL REPORT AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR. CORRECTION INFORMATION: G6: FOLLOW UP #1 H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT ADDITIONAL INFORMATION: H4:DEVICE MANUFACTURE DATE

    Description of Event or Problem · 0

    DOTS IN THE IMAGE. 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
    1910901 PENTAX VIDEO UPPER G.I.SCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG29-I10C 04961333237586

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown