BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRACHYSTEPPER EX3

    MDR report key: 6543766 · Received May 4, 2017

    Report

    Report Number
    1937223-2016-00002
    Event Type
    Malfunction
    Date Received
    May 4, 2017
    Date of Event
    September 21, 2016
    Report Date
    October 21, 2016
    Manufacturer
    CIVCO MEDICAL INSTRUMENTS CO., INC
    Product Code
    ITX
    PMA / PMN Number
    K131161
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT WAS RETURNED FOR INVESTIGATION AND SERVICE. ROTARY ENCODER WAS FOUND TO REPORT "FAILED ERROR CODE" WHEN CONNECTED TO THE COMPUTER. REPLACING THE ENCODER CORRECTED THE PROBLEM WITH THE UNIT AND RETURNED THE ITEM TO FULL OPERATION. (B)(4).

    Description of Event or Problem · 1

    CIVCO WAS NOTIFIED THAT THE SENIOR PHYSICIST FROM A USER FACILITY ENCOUNTERED A DEVICE FAILURE IN THE COURSE OF PREPARING FOR A PROCEDURE. A ROUTINE CHECK OF THE CONNECTION BETWEEN THE CIVCO STEPPER AND THE VARISEED COMPUTER WAS CARRIED OUT BEFORE THE PATIENT BEING ANAESTHETISED. THE STEPPER SYSTEM WORKED CORRECTLY WITH NO INDICATIONS OF ANY PROBLEM. CONTOURING OF THE PROSTATE PROCEEDED AS PER USUAL WITH NO ISSUES ARISING. THE CLINICIAN STEPPED OUT TO SCRUB UP, THEN CHECKED THE SEED CALCULATION BEFORE RETURNING TO USE THE SYSTEM - AT THIS POINT AN ERROR MESSAGE APPEARED ON THE VARISEED SCREEN INDICATING THAT VARISEED WAS UNABLE TO CONNECT TO THE TRACKED STEPPER. ATTEMPTS TO RECTIFY THE PROBLEM FAILED. AS A RESULT OF THE FAILURE ONE PATIENT WAS ANAESTHETISED UNNECESSARILY AND TWO IMPLANTS WERE CANCELLED, TWO FULL SETS OF SEEDS WERE UNUSED. THE PROCEDURE WAS RE-SCHEDULED FOR A LATER TIME. NO PATIENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325188 BRACHYSTEPPER EX3 STEPPER ITX CIVCO MEDICAL INSTRUMENTS CO., INC 620-119LOAN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other