BEUDAMED
    FDA Adverse Event Injury Summary report: N

    USA ELITE SYSTEM STANDARD RESECTOSCOPE SHEATH

    MDR report key: 2516805 · Received March 30, 2012

    Report

    Report Number
    1519132-2012-00021
    Event Type
    Injury
    Date Received
    March 30, 2012
    Report Date
    March 2, 2012
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    HIH
    PMA / PMN Number
    K890328
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE INSTRUMENT CONFIRMS THAT A PIECE OF THE CERAMIC TIP TO BE CHIPPED ON THE TOP EDGE. THE CHIPPED 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. BALANCE OF THE INSTRUMENT IS IN GOOD PHYSICAL SHAPE. 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 PIECED 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

    IT WAS REPORTED TO GYRUS ACMI THAT DURING A SURGICAL PROCEDURE IT WAS NOTICED THAT THE CERAMIC BEAK HAD A CHIP MISSING OUT OF IT. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 USA ELITE SYSTEM STANDARD RESECTOSCOPE SHEATH RESECTOSCOPE SHEATH HIH GYRUS ACMI, INC. EMRS-24B

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN