BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12817571 · Received November 15, 2021

    Report

    Report Number
    9610877-2021-01581
    Event Type
    Malfunction
    Date Received
    November 15, 2021
    Date of Event
    November 11, 2021
    Report Date
    December 17, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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 THAT THE CCD IMAGE FAILURE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE LEAKAGE OCCURRED IN THE CCD MODULE. IN ADDITION, WE CONFIRMED THAT THE SEGMENT WORN OUT; HOWEVER, IT IS 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. CORRECTION INFORMATION: G6: FOLLOW UP #1. H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT.

    Additional Manufacturer Narrative · 0

    MODEL EG29-I10C-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K190805. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Description of Event or Problem · 0

    THERE IS A FOGGY SPOT IN THE CENTER OF THE PICTURE, THE SEGMENT HAS AN UNUSUAL SHAPE, IT BENDS BADLY. THIS EVENT OCCURRED AT THE TIME OF DURING INSPECTION. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711511 PENTAX IMAGINA GASTROSCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG29-I10C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown