BEUDAMED
    FDA Adverse Event Other Summary report: N

    SITESELECT BREAST BIOPSY DEVICE

    MDR report key: 415176 · Received September 6, 2002

    Report

    Report Number
    1824347-2002-00013
    Event Type
    Other
    Date Received
    September 6, 2002
    Report Date
    August 9, 2002
    Manufacturer
    IMAGYN MEDICAL TECHNOLOGIES, INC.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    GARROTE WIRE DID NOT FULLY TRANSECT TISSUE. SURGEON USED SCISSORS TO FINISH TRANSECTING THE LESION. PT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SITESELECT BREAST BIOPSY DEVICE SITESELECT BREAST BIOPSY DEVICE KNW IMAGYN MEDICAL TECHNOLOGIES, INC. SSD015 17F02

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other