BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 14767113 · Received June 22, 2022

    Report

    Report Number
    9610877-2022-00514
    Event Type
    Injury
    Date Received
    June 22, 2022
    Date of Event
    May 18, 2022
    Report Date
    September 7, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EC38-I10L-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K131855. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY THE SCOPE WAS INSPECTED AND NO FAULTS WERE FOUND. IT IS PRESUMED THAT THE PHENOMENON WAS CAUSED BY THE BLURRING OF THE IMAGE DUE TO DIRT ON THE LENS SURFACE. REGARDING THIS PHENOMENON, WE HAVE DETERMINED THAT IT MAY BE DIFFICULT TO REMOVE DIRT FROM THE LENS DUE TO ENVIRONMENTAL FACTORS.

    Description of Event or Problem · 0

    PENTAX MEDICAL BECAME AWARE OF A CUSTOMER REPORTED ON 14-JUN-2022 REPORTING A "FOGGY APPEARANCE DURING THE PROCEDURE" INVOLVING PENTAX MEDICAL VIDEO COLONOSCOPE MODEL EC38-I10NL, SERIAL NUMBER (B)(4). THE ENDOSCOPIST ATTEMPTED TO CLEAR THE SCREEN WITH WATER, AND BY BLOTTING THE SCREEN ON CLEAN PARTS OF THE BOWEL, BUT WITH NO IMPROVEMENT. THIS IS A KNOWN ISSUE THAT THE IS BEING TRACKED AND IS THE REASON THE FACILITY HAD THE LOANER ENDOSCOPE, SO THAT BIOMED COULD REVIEW OUR EQUIPMENT FOR THIS SAME ISSUE. THE REPORTED FAILURE CAUSED AN APPROXIMATE 20 MINUTE DELAY IN THE CASE PER PHYSICIAN RESULTING IN THE PATIENT BEING UNDER ANESTHESIA FOR ADDITIONAL TIME. A SECOND ENDOSCOPE WAS REQUIRED TO COMPLETE THE PROCEDURE. THE MODEL AND SERIAL NUMBERS OF THE SECOND ENDOSCIPE WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2158395 PENTAX VIDEO COLONOSCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10NL

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Other