BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12451818 · Received September 10, 2021

    Report

    Report Number
    9610877-2021-00798
    Event Type
    Malfunction
    Date Received
    September 10, 2021
    Date of Event
    January 8, 2021
    Report Date
    December 21, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 EG-2990I IS AVAILABLE IN THE USA WITH A 510K NUMBER K131902.

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: THE AGING WATERPROOF CAP WAS NOT TIGHTLY SEALED, RESULTING IN WATER SEEPAGE OF THE ELECTRICAL CONNECTOR ASSY. CORRECTION INFORMATION: FOLLOW UP #1, TYPE OF FOLLOW UP, CODING CHANGED BASED ON THE INVESTIGATION RESULT.

    Description of Event or Problem · 0

    DURING USE, IMAGE COLOR DISTORTION. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1349396 PENTAX VIDEO GASTROSCOPE VERSION-C FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG-2990ZI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown