BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12872874 · Received November 24, 2021

    Report

    Report Number
    9610877-2021-01668
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Date of Event
    November 18, 2021
    Report Date
    April 5, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    ODG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 EG38-J10UT-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K200090.

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: THE DEFECT PARTS HAVE BEEN REPLACED. 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

    US-PROBE LEAKY. 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
    1768881 PENTAX ULTRASOUND GASTROSCOPE FAMILY ODG HOYA CORPORATION PENTAX TOKYO OFFICE EG38-J10UT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown