BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12827713 · Received November 17, 2021

    Report

    Report Number
    9610877-2021-01462
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    October 19, 2021
    Report Date
    November 17, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    UDI-DI
    04961333228430
    PMA / PMN Number
    K131855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED AT PENTAX SERVICE FACILITY FOR FURTHER EVALUATION ON SERVICE ORDER (B)(4). THE DEVICE WAS INSPECTED WHERE THE USER NARRATIVE WAS CONFIRMED. INSPECTION FINDINGS ARE AS FOLLOWS: IMAGE BLACKOUT; FLUID INVASION IN SEGMENT SECTION; FLUID INVASION IN CONTROL BODY; PVE ELECTRICAL PIN CORRODED; CONTROL BODY SEVERE CORROSION INSIDE; CCD CIRCUIT BOARD CORROSION; FAILED DRY LEAK TEST; PVE ELECTRICAL CONNECTOR FRAME HAS SEVERE CORROSION; ENDOSCOPE FAILED ELECTRICAL SAFETY TEST - PLCT; FAILED WET LEAK TEST; LEAK AT BIOPSY CHANNEL (LARGE/ PRIMARY) INLET SIDE LEAK AT BIOPSY CHANNEL (LARGE/ PRIMARY) DISTAL SIDE; PRIMARY OPERATION CHANNEL RESISTANCE; SEGMENT CORRODED; FLUID INVASION IN PVE CONNECTOR; # 2 REMOTE CONTROL BUTTON COVER CRACKED; #4 REMOTE CONTROL BUTTON NOT WORKING; FLUID INVASION TO INSERTION TUBE; CUSTOMER COMPLAINT CONFIRMED; FLUID INVASION IN UMBILICAL LIGHT GUIDE CABLE; FLUID DAMAGE TO LIGHT CARRYING BUNDLE; #3 REMOTE CONTROL BUTTON NOT WORKING; #2 REMOTE CONTROL BUTTON NOT WORKING; #1 REMOTE CONTROL BUTTON NOT WORKING; UP/ DOWN GUIDE PLATE CORRODED; INSERTION TUBE ROOT BRACE CUT. THE DEVICE IS IN THE PROCESS OF BEING REPAIR WHERE ALL DEFECTS FOUND WILL BE REMEDIATED AND RETURNED TO THE USER UPON COMPLETION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF AN EVENT WHICH OCCURRED IN THE (B)(6) INVOLVING PENTAX VIDEO SCOPE EC-3890LI. IN THE EVENT REPORTED, THE USER STATED BLACK FLUID COMING OUT OF SCOPE. THE TIMING OF THE EVENT WAS DURING THE REPROCESSING IN THE REPROCESSING ROOM. THERE WAS NO ADVERSE EVENT REPORTED WITH THIS COMPLAINT. NO OTHER INFORMATION PROVIDED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1725150 PENTAX VIDEO COLONOSCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC-3890LI 04961333228430

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown