BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPRI APPLICATOR

    MDR report key: 3866581 · Received June 2, 2014

    Report

    Report Number
    MW5036471
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 30, 2014
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    JAQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT RECEIVING TREATMENT UTILIZING VARIAN CAPRI DISPOSABLE SINGLE-USE TREATMENT DEVICE IN RADIATION ONCOLOGY. DEVICE HAS A SOFT FOAM CORE AND 13 LUMENS/CHANNELS FOR THE HDR BRACHYTHERAPY SOURCE TO TRAVEL WITHIN. DEVICE IS INFLATABLE. CHANNEL 1, THE MOST DISTAL CHANNEL, WAS NOT IN THE SAME LOCATION AS ALL OTHER CAPRI'S USED. IT WAS LATER DISCOVERED TO BE APPROX 1.0CM INFERIOR OF MFR SPECS. PT WAS TREATED WITH THIS DEVICE AND DID NOT RECEIVE THE PRESCRIBED DOSE TO ALL PARTS OF THE TUMOR AS WOULD NORMALLY OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321353 CAPRI APPLICATOR CAPRI APPLICATOR JAQ VARIAN MEDICAL SYSTEMS 1311-2043

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR