BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 1951041 · Received December 28, 2010

    Report

    Report Number
    MW5018837
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    October 29, 2010
    Report Date
    December 28, 2010
    Manufacturer
    PENTAX MEDICAL
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IN FOR SCREENING COLONOSCOPY. THE PENTAX COLONOSCOPE WAS CHECKED PRIOR TO THE PROCEDURE STARTING AND WAS WORKING APPROPRIATELY. MIDWAY THROUGH A VERY DIFFICULT COLONOSCOPY, THE PICTURE ON THE MONITOR DEVELOPED HORIZONTAL LINES WITH SPORADIC FLASHES OF LIGHT, WHICH MADE THE PICTURE VERY DIFFICULT TO SEE. THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTAX COLONOSCOPE/LIGHT SOURCE MONITOR FDF PENTAX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other