BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12951150 · Received December 7, 2021

    Report

    Report Number
    9610877-2021-01619
    Event Type
    Malfunction
    Date Received
    December 7, 2021
    Report Date
    December 7, 2021
    Manufacturer
    HOYA CORPORATION PENTAX
    Product Code
    FDF
    UDI-DI
    04961333172085
    PMA / PMN Number
    K131855
    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 NOT CONFIRMED THROUGH EVALUATION OF THE DEVICE. EVALUATION FINDINGS WERE LISTED AS: PVE ELECTRICAL CONNECTOR FRAME MILD CORROSION, PASSED BOTH DRY AND WET LEAK TEST, LIGHT CARRYING BUNDLE LESS THAN 70% TRANSMISSION. THE DEVICE WAS CLEANED AND DISINFECTED, WITH ANGULATION ADJUSTMENT AND VIDEO IMAGE CALIBRATION PERFORMED AND 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 A EC38-I10L- VIDEO COLONOSCOPE, INDICATING THAT THERE WAS NO VIDEO IMAGE. THE ISSUE WAS OBSERVED IN THE OPERATING ROOM PRIOR TO USE. THERE WERE NO PATIENT OR USER INJURIES, ADVERSE EVENTS, DELAY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1848890 PENTAX VIDEO COLONOSCOPE FDF HOYA CORPORATION PENTAX EC38-I10L 04961333172085

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown