BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALYPSO BEACON TRANSPONDERS

    MDR report key: 2122097 · Received May 9, 2011

    Report

    Report Number
    2122097
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 3, 2011
    Manufacturer
    CALYPSO MEDICAL TECHNOLOGIES
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE BEACON NEEDLES WERE LOADED IN THE NORMAL WAY. I VISUALLY SAW THE IMPLANT GO INTO THE NEEDLE AND FELT IT IN THE NEEDLE AFTER LOADING. I THEN PLACED THEM ON MY BACK TABLE UNTIL WE WOULD NEED THEM. THE PATIENT WAS BROUGHT INTO THE OPERATING, THE ANESTHESIA PROVIDER THEN PUT THE PATIENT TO SLEEP. THE RN AND MYSELF POSITIONED THE PATIENT AND THE RN THEN PREPPED THE PATIENT FOR THE SURGERY. DR. (B)(6) USED ULTRASOUND TO INSERT THE BEACON NEEDLES AND IMPLANTS. HE SAID HE SAW THE IMPLANTS ONCE PLACED. WE FINISHED THE SURGERY AND C-ARM WAS CALLED IN TO ENSURE PLACEMENT IN THE USUAL FASHION. ONCE THE C-ARM TECH CAME INTO THE ROOM, SETUP HIS MACHINE, TOOK THE X-RAY IMAGE AND THE BEACON IMPLANTS WERE NOT VISIBLE ON X-RAY. AFTER CONSULTING WITH THE PHYSICISTS IT WAS DECIDED TO GET A CT SCAN OF THE PATIENT AND SEE IF THEY WERE DETECTED ON CT SCAN. IF THEY WERE NOT DR. (B)(6) SAID HE WOULD RESCHEDULE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALYPSO BEACON TRANSPONDERS NONE IYE CALYPSO MEDICAL TECHNOLOGIES 2012-11-16 00010706

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR