BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTUS 3000 THYROID UPTAKE SYSTEM

    MDR report key: 8026941 · Received October 31, 2018

    Report

    Report Number
    2518443-2018-00001
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    October 4, 2018
    Report Date
    October 31, 2018
    Manufacturer
    CAPINTEC, INC.
    Product Code
    IZD
    PMA / PMN Number
    CLASS I,EXEM
    Removal / Correction Number
    2518443-11/01/18-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2018 CAPINTEC WAS INFORMED OF AN ARM FAILURE ON A CAPTUS 3000 THYROID UPDATE SYSTEM- SERIAL NUMBER (B)(4). A COMPONENT IN THE SPRING ARM (TENSION ROD) BROKE CAUSING THE ARM WITH THE COLLIMATOR TO FALL DOWNWARD. THE PATIENT WAS SEATED IN A CHAIR AND THE TECHNOLOGIST WAS PREPARING TO PERFORM A THYROID UPTAKE PROCEDURE ON THE PATIENT. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862760 CAPTUS 3000 THYROID UPTAKE SYSTEM THYROID UPTAKE SYSTEM IZD CAPINTEC, INC. 5430-0077

    Patients

    Seq Age Sex Outcome Treatment
    1