BEUDAMED
    FDA Adverse Event Other Summary report: N

    ROTATING CF RESECTOSCOPE INNER SHEATH

    MDR report key: 2401125 · Received January 4, 2012

    Report

    Report Number
    1519132-2011-00038
    Event Type
    Other
    Date Received
    January 4, 2012
    Report Date
    December 5, 2011
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FJL
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION FROM THE HOSPITAL HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFORMATION BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE WHILE USING THE ROTATING CF RESECTOSCOPE INNER SHEATH, THE CERAMIC TIP BROKE OFF IN THE PATIENT, THE SURGEON WAS ABLE TO REMOVE IT WITH NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTATING CF RESECTOSCOPE INNER SHEATH ROTATING CF RESECTOSCOPE INNER SHEATH FJL GYRUS ACMI, INC. ERIS-CF25

    Patients

    Seq Age Sex Outcome Treatment
    1