BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 15686988 · Received October 27, 2022

    Report

    Report Number
    9610877-2022-00616
    Event Type
    Malfunction
    Date Received
    October 27, 2022
    Date of Event
    August 16, 2022
    Report Date
    December 22, 2022
    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

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EC38-I10CL-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K190805. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: THE EVENT IS CONSIDERED TO BE A BLURRED IMAGE DUE TO DIRT ON THE LENS SURFACE. ONLY IN SPECIFIC AREAS, IT IS POSSIBLE THAT THE DIRT ON THE LENS IS DIFFICULT TO REMOVE DUE TO ENVIRONMENTAL FACTORS, AND THE EVENT IS CONSIDERED NOT DUE TO MANUFACTURING/DESIGN-ORIGINATED ISSUE BASED ON THE INVESTIGATIONS AT THIS TIME. IF THE LENS IS DIRTY AND THE RANGE IS LIMITED, THE INSPECTION CAN BE CONTINUED, AND IF THE LENS IS VERY DIRTY, THE LENS CAN BE REMOVED AND WIPED. AS FOR LENS DIRT, THE SYMPTOMS OCCUR IMMEDIATELY AFTER USE, SO IT IS CONSIDERED EXTREMELY UNLIKELY THAT PERFORATION OR HEAVY BLEEDING WILL LEAD TO CLOUDING AND LEAD TO SERIOUS EVENTS. FOR THE ABOVE REASONS, IT HAS NOT OCCURRED FREQUENTLY AND THE POSSIBILITY OF HARM IS LOW, SO IT IS JUDGED THAT NO ACTION IS NECESSARY.

    Description of Event or Problem · 0

    PENTAX CANADA RECEIVED NOTIFICATION OF THIS INCIDENT AT THE ELK VALLEY HOSPITAL THROUGH HEALTH CANADA'S CMDSNET PROGRAM. CUSTOMER REPORTED THAT DURING A COLONOSCOPY, THE PENTAX COLONOSCOPE BEING USED BECAME BLURRY IN PARTS OF THE SCREEN AND WAS UNABLE TO BE CLEARED. DURING THE INITIAL SCOPE TESTING, THE WINDSHIELD FLUID WAS WORKING AND FLOWING ACROSS THE SCREEN WELL. THE SCOPE WAS USED TO FINISH THE PROCEDURE, ALTHOUGH CAUSED IMPAIRED VISION. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2911670 PENTAX VIDEO COLONOSCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10NL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown