BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 17057009 · Received June 5, 2023

    Report

    Report Number
    9610877-2023-00152
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Date of Event
    January 1, 2023
    Report Date
    August 6, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION B4: DATE OF THIS REPORT G6: FOLLOW UP #1 H2:IF FOLLOW-UP, WHAT TYPE? H3:DEVICE EVALUATED BY MANUFACTURE H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT ADDITIONAL INFORMATION H4:DEVICE MANUFACTURE DATE EVALUATION SUMMARY DEVICE WAS RETURNED TO PENTAX MEDICAL CANADA INC. FOR EVALUATION AND REPAIR. RETURNED TO CUSTOMER ON 16-JUN-2023. WE HAVE DETERMINED THAT THE POTENTIAL/ROOT CAUSE OF THE FAILURE IS LIKELY TO BE ENVIRONMENTAL. PRESUMED ENVIRONMENT: LIPID-RICH RESIDUALS DUE TO INADEQUATE PRETREATMENT, WHICH ADHERE TO THE LENS SURFACE. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED PENTAX MEDICAL MIYAGI ON 04-FEB-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 04-FEB-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. INVESTIGATION IS IN-PROCESS. 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 IMAGE BLURRINESS/FOGGINESS DURING PROCEDURES. HAS HAD TO CANCEL PATIENTS. THE FOLLOWING IS BEING USED AT THE SITE: OVAL IN IRRIGATION, PRO-ADVANTAGE LUBRICATING JELLY, USES MEDIVATOR ADVANTAGE PLUS WITH INTERCEPT. ON SITE SALES PERSON HAS SEEN THE BLURRINESS, HAPPENS MID PROCEDURE, STUFF STICKS TO LENS WONT WASH OFF, BECOMES FOGGY. DESCRIPTION OF ANY ACTIONS TAKEN: STOPPED USING OVAL. STOPPED USING PRO-ADVANTAGE PLUS. NOT SURE WHAT THEY ARE USING NOW, BUT SHOULD BE EITHER KY OR HEALTHCARE PLUS. THIS EVENT OCCURRED AT THE TIME OF DURING USE. B3:NOT KNOWN FOR THE EXACT DATE, WE JUST KNOW THE YEAR THE COMPLAINT WAS SENT IN TO MANUFACTURER. 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
    32473 PENTAX VIDEO COLONO SCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10NL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown