BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12786368 · Received November 10, 2021

    Report

    Report Number
    9610877-2021-01399
    Event Type
    Malfunction
    Date Received
    November 10, 2021
    Report Date
    November 10, 2021
    Manufacturer
    HOYA CORPORATION PENTAX
    Product Code
    FDF
    UDI-DI
    04961333172085
    PMA / PMN Number
    K190805
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED CUSTOMER COMPLAINT OF NO VIDEO IMAGE WAS CONFIRMED THROUGH EVALUATION OF THE DEVICE. EVALUATION FINDINGS WERE LISTED AS: PVE CONNECTOR HOUSING CRACKED, LEAK AT THE PVE CONNECTOR, IMAGE BLACKOUT, FLUID "INVATION" IN CONTROL BODY, PVE ELECTRICAL PIN AND CIRCUIT BOARD CORROSION, UP ANGULATION AND RIGHT ANGULATION DECREASED, FAILED DRY LEAK TEST, PVE ELECTRICAL CONNECTOR FRAME WITH SEVERE CORROSION IN ADDITION TO : RIGHT- UP-LEFT AND DOWN STAYCOILS ALL CORRODED, DOWN AND UP WIRE CORRODED, FAILED WET LEAK TEST, LEFT ANGULATION DECREASED, FLUID INVATION IN PVE CONNECTOR, REMOTE CONTROL BUTTON COVER CRACKED, BENDING RUBBER PINHOLE, FLUID INVASION OF THE INSERTION TUBE, LEFT ANGLE WIRE CORRODED, DOWN ANGULATION DECREASED, AIR/WATER SOCKET CYLINDER O-RING CHIPPED, FLUID INVATION IN THE UMBILICAL LIGHT GUIDE CABLE, SHIELD COVER AND CONTROL BODY CORRODED, FLUID DAMAGE TO LIGHT CARRYING BUNDLE, RIGHT ANGLE WIRE CORRODED AND SUCTION TUBE TWISTED AND KINKED. THE DEVICE WAS REFURBISHED, CLEANED AND DISINFECTED, VIDEO IMAGE CALIBRATED AND ANGLE ADJUSTMENTS WERE PERFORMED AND THE DEVICE WAS RETURNED TO THE CUSTOMER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    A CUSTOMER REQUESTED A RMA FOR NO VIDEO IMAGE ON A EC38-I10L- VIDEO COLONOSCOPE. THE ISSUE WAS OBSERVED IN THE OPERATING ROOM PRIOR TO USE DURING PRE-INSPECTION CHECK. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORT OF AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1688994 PENTAX VIDEO COLONOSCOPE FDF HOYA CORPORATION PENTAX EC38-I10L 04961333172085

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown