BEUDAMED
    FDA Adverse Event Other Summary report: N

    ROTATING CF RESECTOSCOPE INNER SHEATH

    MDR report key: 2500873 · Received March 19, 2012

    Report

    Report Number
    1519132-2012-00013
    Event Type
    Other
    Date Received
    March 19, 2012
    Date of Event
    February 21, 2012
    Report Date
    February 21, 2012
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FDC
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE INSTRUMENT CONFIRMS THAT A PIECE OF THE CERAMIC TIP IS BROKEN OFF. THE BROKEN PIECE OF CERAMIC WAS NOT RETURNED WITH THE UNIT. THE BALANCES OF THE CERAMIC TIP REMAINS SECURELY GLUED INSIDE THE DISTAL END OF THE SHEATH TUBE. ALSO NOTED ARE MINOR DENTS ALONG THE STEEL TUBE. THE EXACT CAUSE OF THE BROKEN CERAMIC TIP CANNOT BE DETERMINED DUE TO THE CERAMIC TIP NOT BEING RETURNED. THE DENTS / DAMAGE ON THE STEEL TUBE ALONG WITH THE REMNANTS OF THE ADHESIVE ON THE INSIDE OF THE TUBE INDICATES THE CAUSE OF THIS FAILURE IS LIKELY DUE TO DAMAGE CAUSED BY THE CUSTOMER. COMMON CAUSES OF CERAMIC TIP DAMAGE AS DETERMINED FROM PRIOR INVESTIGATIONS ARE NOTED BELOW: 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 INSTRUCTIONS FOR USE MANUAL THAT IS SHIPPED WITH THE INSTRUMENT. DROPPING THE INSTRUMENT OR GETTING 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. EXPOSURE OF LASER ENERGY TO THE CERAMIC TIP, WHICH CAN CAUSE OVERHEATING AND CRACKING / BREAKING OF THE CERAMIC MATERIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THE TIP OF THE INNER SHEATH BROKE OFF INSIDE THE PATIENT. THE PART WAS RECOVERED AND THERE WAS NO PATIENT INJURY. THEY COMPLETED THE CASE WITH ANOTHER LIKE DEVICE.

    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 UNK