BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 13262988 · Received January 16, 2022

    Report

    Report Number
    9610877-2022-00143
    Event Type
    Malfunction
    Date Received
    January 16, 2022
    Date of Event
    January 12, 2022
    Report Date
    March 11, 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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    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. IN ADDITION, WE CONFIRMED THAT THE LG CABLE CONNECTOR HOUSING LEAKAGE; 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 INFORMATION: H4: DEVICE MANUFACTURE DATE.

    Description of Event or Problem · 0

    FOGGY IMAGE. MOISTURE INSIDE. A/W SOCKET LOOSENED. 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
    701657 PENTAX IMAGINA GASTROSCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG29-I10C 04961333237586

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown