BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 2341656 · Received November 10, 2011

    Report

    Report Number
    MW5023114
    Event Type
    Malfunction
    Date Received
    November 10, 2011
    Date of Event
    November 9, 2011
    Report Date
    November 10, 2011
    Manufacturer
    PENTAX MEDICAL COMPANY
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PIECES OF THE SCOPE SLEEVE BROKE OFF OF SCOPE IN PT DURING COLONOSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTAX COLONOSCOPE FDF PENTAX MEDICAL COMPANY EC-3430L

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other