BEUDAMED
    FDA Adverse Event Injury Summary report: N

    USA ELITE SYSTEM ROTATING CONTINUOUS FLOW

    MDR report key: 2123401 · Received November 12, 2008

    Report

    Report Number
    2123401
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    February 26, 2008
    Report Date
    October 30, 2008
    Manufacturer
    GYRUS ACMI
    Product Code
    FJL
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    GYRUS SHEATH CAT #CE0344 TIP BROKE OFF WHILE IN USE ON A PATIENT. COULD NOT BE REMOVED THROUGH SHEATH. PATIENT REQUIRED OPEN SURGICAL PROCEDURE AND HOSPITALIZATION AS A RESULT OF THE PRODUCT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 USA ELITE SYSTEM ROTATING CONTINUOUS FLOW RESECTOSCOPE SHEATH 25.6 FJL GYRUS ACMI ERIS-CF25 +H883ERISCF253T*

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R