BEUDAMED
    FDA Adverse Event Other Summary report: N

    ROTATING CF RESECTOSCOPE INNER SHEATH

    MDR report key: 2440869 · Received January 31, 2012

    Report

    Report Number
    1519132-2012-00003
    Event Type
    Other
    Date Received
    January 31, 2012
    Date of Event
    December 12, 2012
    Report Date
    January 6, 2012
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FDC
    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 OF THE SHEATH TUBE. THE BALANCE OF THE CERAMIC TIP REMAINS SECURELY GLUED INSIDE THE DISTAL END OF THE SHEATH TUBE. THE BROKEN PIECE OF CERAMIC WAS RETURNED WITH THE UNIT. A SIGNIFICANT CHIP AND A CRACK ARE NOTED ON THE BROKEN PIECE THAT CONTINUES FROM THE FRACTURE SITE TO THE BASE OF THE COMPONENT. ALSO NOTED ARE MINOR DENTS ALONG THE TUBE. CONCLUSION: THE EXACT CAUSE OF THE BREAKAGE OF THE CERAMIC TIP CANNOT BE DETERMINE, BUT DUE TO THE EVIDENCE OF THE CHIP AND CRACK NOTED ON THE BROKEN PIECE OF CERAMIC, IT IS REASONED THAT EXCESSIVE FORCE OR PHYSICAL TRAUMA WAS INFLICTED TO THE TIP OF THE DEVICE. IT IS IMPORTANT TO REITERATE THAT THE BASE OF THE CERAMIC TIP REMAINS SECURED IN THE INSTRUMENT, INDICATING THAT THE EPOXY FUNCTIONED APPROPRIATELY.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE THE TIP BROKE OFF THE INSTRUMENT AND FELL INTO THE PT. SURGEON RETRIEVED ALL OF THE PIECES. 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 FDC GYRUS ACMI, INC. ERIS-CF25

    Patients

    Seq Age Sex Outcome Treatment
    1