BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSYS MICROMARK II

    MDR report key: 206148 · Received January 11, 1999

    Report

    Report Number
    1527736-1999-00166
    Event Type
    Malfunction
    Date Received
    January 11, 1999
    Report Date
    December 16, 1998
    Manufacturer
    BIOPSYS MEDICAL, INC.
    Product Code
    KNW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING A BREAST BIOPSY. IT WAS REPORTED THE PHYSICIAN NOTICED THE MARKER SLEEVE WAS MISSING AFTER REMOVAL OF THE MARKER FROM THE PROBE. THE PHYSICIAN ASSUMED THE SLEEVE WAS LEFT IN THE PT. THE CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPSYS MICROMARK II BIOPSYS KNW BIOPSYS MEDICAL, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other