BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12544835 · Received September 28, 2021

    Report

    Report Number
    9610877-2021-00962
    Event Type
    Malfunction
    Date Received
    September 28, 2021
    Date of Event
    September 9, 2021
    Report Date
    January 24, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    PMA / PMN Number
    K131855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: THIS DEVICE HAS BEEN REPAIRED. THE LCB REPLACED.

    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. EC-3890LI-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K131855.

    Description of Event or Problem · 0

    THE LCB IS BROKEN. THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1442026 PENTAX HDVIDEO COLONOSCOPE 3.8C 13.2T 1700L FWJ FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC-3890FI2

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown