BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONT. FLOW RESECTOSCOPE INNER SHEATH

    MDR report key: 2464126 · Received February 14, 2012

    Report

    Report Number
    1519132-2012-00008
    Event Type
    Other
    Date Received
    February 14, 2012
    Date of Event
    December 13, 2012
    Report Date
    January 18, 2012
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    HIH
    PMA / PMN Number
    K890328
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. 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 FRACTURE 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 CYSTOSCOPY SURGICAL PROCEDURE WHILE USING THE 27 IS CFR RESECTOSCOPE, THE SHEATH BROKE INTO SEVERAL PIECES. ALL PIECES WERE RETRIEVED WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONT. FLOW RESECTOSCOPE INNER SHEATH CONT. FLOW RESECTOSCOPE INNER SHEATH HIH GYRUS ACMI, INC. 27-IS-CFR

    Patients

    Seq Age Sex Outcome Treatment
    1