BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 2434097 · Received January 25, 2012

    Report

    Report Number
    2518897-2011-00007
    Event Type
    Injury
    Date Received
    January 25, 2012
    Date of Event
    November 9, 2011
    Report Date
    January 25, 2012
    Manufacturer
    PENTAX MEDICAL COMPANY
    Product Code
    FDF
    PMA / PMN Number
    K951574
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2012. THE DEVICE WAS BORROWED FROM ANOTHER FACILITY WITHIN THE REPORTING FACILITIES MEDICAL SYSTEM GROUP. THE DEVICE HAS BEEN QUARANTINED BY THE REPORTING FACILITY PENDING INVESTIGATION OF THE EVENT. THE INVESTIGATION IS ON GOING.

    Description of Event or Problem · 1

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

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention