BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVI APPLICATOR

    MDR report key: 2513648 · Received March 13, 2012

    Report

    Report Number
    2032338-2012-00001
    Event Type
    Malfunction
    Date Received
    March 13, 2012
    Date of Event
    January 20, 2012
    Report Date
    February 13, 2012
    Manufacturer
    CLANNA MEDICAL
    Product Code
    MIJ
    PMA / PMN Number
    K081677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOREIGN BODY RETRIEVED DURING THE (B)(6) 2012 PROCEDURE WAS RECEIVED BY THE COMPANY ON (B)(4) 2012. IT WAS CONFIRMED VISUALLY THAT THE COMPONENT WAS THE TIP OF THE SAVI DEVICE. ENGINEERING EVALUATION CONCLUDED THAT A MANUFACTURING GLUE PROCESS WAS INADEQUATE OR INCOMPLETE RESULTING IN THE IMPROPER ATTACHMENT OF THE TIP.

    Description of Event or Problem · 1

    A COMPANY REPRESENTATIVE RECEIVED AN E-MAIL FROM A CUSTOMER STATING THAT AT A SIX MONTH FOLLOWUP VISIT SUBSEQUENT TO LUMPECTOMY AND APBI TREATMENT USING THE SAVI DEVICE, THE MAMMOGRAM IMAGE SHOWED AN ARTIFACT THAT APPEARED TO BE A FOREIGN BODY. THE SHAPE OF THE ARTIFACT RESEMBLED THE SHAPE OF THE SAVI TIP. SUBSEQUENT ULTRASOUND EVALUATION CONFIRMED THAT THE MAMMOGRAM IMAGE WAS A FOREIGN BODY. ON (B)(6), 2012, A PROCEDURE WAS PERFORMED TO RETRIEVE THE FOREIGN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAVI APPLICATOR RADIO-NUCLIDE APPLICATOR MIJ CLANNA MEDICAL SAVI-08 ML00789

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention