BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 16518794 · Received March 9, 2023

    Report

    Report Number
    9610877-2023-00087
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    October 13, 2022
    Report Date
    May 19, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: BASED ON THE CONTENT OF INVESTIGATED DATA, IT WAS DETERMINED THAT THE POTENTIAL CAUSE/ROOT CAUSE OF FAILURE WAS THAT THE VISIBILITY BECAME UNCLEAR DUE TO THE DIFFICULTY IN REMOVING THE MUCUS ADHERING TO THE SURFACE OF THE OBJECTIVE LENS DURING THE ENDOSCOPY. A DEVICE HISTORY RECORD(DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED PENTAX MEDICAL MIYAGI ON 27-JAN-2021 UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO REWORKS OR CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED ON 27-JAN-2021. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS NOT DISTRIBUTED IN US SO THAT 510K IS BLANK. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Description of Event or Problem · 0

    PATIENT INVOLVED - NO KNOWN ADVERSE EVENT. CUSTOMER REPORTED COLONOSCOPE L110658: STOOL NOT CLEARING FROM THE MIDDLE OF THE LENS. ORANGE SPOT IN MIDDLE OF LENS. NOTE: PENTAX CANADA RECEIVED NOTIFICATION OF THIS INCIDENT AT CRESTON VALLEY HOSPITAL AND HEALTH CENTRE THROUGH HEALTH CANADA'S CMDSNET PROGRAM. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1735310 PENTAX VIDEO COLONOSCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10NL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown