BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROPASS URETERAL ACCESS SHEATH

    MDR report key: 2032213 · Received March 3, 2011

    Report

    Report Number
    2032213
    Event Type
    Malfunction
    Date Received
    March 3, 2011
    Date of Event
    January 20, 2011
    Report Date
    March 3, 2011
    Manufacturer
    GYRUS ACMI
    Product Code
    KNY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE INSIDE OF THE SHEATH SHREDDED WHEN THE SURGEON INSERTED THE SCOPE. IT WAS UNABLE TO BE USED. THE SALES REP IS AWARE AND A REPORT WAS FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UROPASS URETERAL ACCESS SHEATH ACCESS SHEATH KNY GYRUS ACMI * 09F1000336

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR NO OTHER THERAPIES