BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12776116 · Received November 8, 2021

    Report

    Report Number
    9610877-2021-01483
    Event Type
    Malfunction
    Date Received
    November 8, 2021
    Date of Event
    November 1, 2021
    Report Date
    March 10, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    ODG
    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 EG38-J10UT-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K200090. 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

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODELEG38-J10UT-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K200090. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Description of Event or Problem · 0

    IMAGE DISTURBANCES BY ANGULATION. 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
    1674134 PENTAX DIGITAL LINEAR ULTRASOUND SCOPE ODG HOYA CORPORATION PENTAX TOKYO OFFICE EG38-J10UT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown