BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUOUS FLOW INNER SHEATH

    MDR report key: 6215654 · Received December 30, 2016

    Report

    Report Number
    6215654
    Event Type
    Malfunction
    Date Received
    December 30, 2016
    Date of Event
    November 24, 2016
    Report Date
    December 7, 2016
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FJL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A CYSTOSCOPY, A SMALL PLASTIC PIECE OF THE RESECTOSCOPE HAD BROKEN. THE DOCTOR REPORTED THAT HE/SHE WAS ABLE TO RECOVER THE SMALL AND LARGE PLASTIC PIECES. WHILE WE CAN NOT BE SURE THAT 100% OF THE FRAGMENTS WERE LOCATED, THE DOCTOR DID A THOROUGH SEARCH FOR A LONG PERIOD OF TIME AND NEEDED TO PROCEED WITH THE PROCEDURE. THE PROCEDURE CONTINUED WITHOUT FURTHER COMPLICATIONS AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN GOOD CONDITION. THERE WERE NO COMPLICATIONS. PER OUR STERILE PROCESSING DEPARTMENT THIS FACILITY IS FOLLOWING GYRUS ACMI'S RECOMMENDATIONS FOR CLEANING AND STERILIZING. OUR SPD SUPERVISOR DID POST A NOTE ON THE INSTRUCTIONS FOR CLEANING/STERILIZING THE DEVICES FOR STAFF TO PAY EXTRA ATTENTION TO THE INTEGRITY OF ALL OF THE PIECES. HTTP://WWW.ONESOURCEDOCS.COM/MEMBER/SHOW-DOCUMENT.HTML?ID=208551

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866255 CONTINUOUS FLOW INNER SHEATH RESECTOSCOPE SHEATH FJL GYRUS ACMI, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other