BEUDAMED
    FDA Adverse Event Other Summary report: N

    ROTATING CF RESECTOSCOPE INNER SHEATH

    MDR report key: 2434667 · Received January 27, 2012

    Report

    Report Number
    1519132-2012-00001
    Event Type
    Other
    Date Received
    January 27, 2012
    Date of Event
    December 27, 2011
    Report Date
    December 28, 2011
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FJL
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE INSTRUMENT CONFIRMS THAT THE CERAMIC TIP IS BROKEN OFF THE SHEATH TUBE. THE BROKEN PIECE OF CERAMIC WAS NOT RETURNED WITH THE UNIT. THE BALANCE OF THE CERAMIC TIP REMAINS SECURELY GLUED INSIDE THE DISTAL END OF THE SHEATH TUBE. ALSO NOTED ARE MULTIPLE DENTS ALONG THE STEEL TUBE. A SEARCH OF PRIOR INCIDENTS FOR THIS TYPE OF INSTRUMENT WITH THE SAME OR SIMILAR VERBIAGE IN THE PROBLEM DESCRIPTION REVEALS SEVERAL COMMON ROOT CAUSES AS FOLLOWS: APPLICATION OF EXCESSIVE LATERAL FORCE ON THE INSTRUMENT DURING INSERTION OR REMOVAL FROM THE CYSTO SHEATH, WHICH FRACTURES THE CERAMIC AND CAUSES PIECES OF THE CERAMIC TO BREAK FROM THE TIP. DENTS OR OTHER DAMAGE TO THE STEEL TUBE ARE INDICATORS OF THIS TYPE OF MISUSE. PLEASE NOTE THAT THIS MISHANDLING IS CAUTIONED AGAINST IN THE INSTRUCTION FOR USE MANUAL THAT IS SHIPPED WITH THE INSTRUMENT. EXPOSURE OF LASER ENERGY TO THE CERAMIC TIP, WHICH CAN CAUSE OVERHEATING AND CRACKING/BREAKING OF THE CERAMIC MATERIAL. DROPPING THE INSTRUMENT OR HITTING THE TIP AGAINST OTHER INSTRUMENTS OR AGAINST STERILIZATION CONTAINERS IS ANOTHER COMMON CAUSE OF CERAMIC TIP BREAKAGE. THIS TYPE OF DAMAGE TO THE CERAMIC TIP CAN RESULT IN COMPLETE SEPARATION OF THE TIP OR POSSIBLY CHIPS OR CRACKS IN THE TIP THAT WILL LEAD TO FAILURE DURING SUBSEQUENT HANDLING OR USE.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE THE CERAMIC BEAK FROM END OF THE SHEATH BROKE OFF IN THE PTS BLADDER. SURGEON USED A GRASPER TO PULL THE PIECE OUT. NO HARM OR EXTENDED STAY FOR THE PT.

    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