BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSYS MARKER CLIP WITH INTRODUCER

    MDR report key: 204310 · Received December 28, 1998

    Report

    Report Number
    1527736-1998-04415
    Event Type
    Malfunction
    Date Received
    December 28, 1998
    Date of Event
    December 3, 1998
    Report Date
    December 3, 1998
    Manufacturer
    BIOPSYS MEDICAL, INC.
    Product Code
    KNW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING A BREAST BIOPSY. IT WAS REPORTED THE MARKER SLEEVE WAS LEFT IN THE BREAST AFTER THE CLIP WAS DEPLOYED. THE CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPSYS MARKER CLIP WITH INTRODUCER BIOPSYS KNW BIOPSYS MEDICAL, INC. NA W6837

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other