BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 13015056 · Received December 15, 2021

    Report

    Report Number
    9610877-2021-01824
    Event Type
    Malfunction
    Date Received
    December 15, 2021
    Date of Event
    December 3, 2021
    Report Date
    March 14, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    UDI-DI
    04961333237869
    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 EC38-I10CL-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 EC38-I10CL-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 OBJECTIVE LENS DIRTY; 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.

    Description of Event or Problem · 0

    MANY SPOTS IN THE IMAGE, MOISTURE UNDER THE LED . 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
    1911129 PENTAX VIDEO COLONO SCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10CL 04961333237869

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown