BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSYS MARKER CLIP WITH INTRODUCER

    MDR report key: 200585 · Received December 4, 1998

    Report

    Report Number
    1527736-1998-03913
    Event Type
    Malfunction
    Date Received
    December 4, 1998
    Date of Event
    November 12, 1998
    Report Date
    November 12, 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
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THAT THE DEVICE WAS USED DURING A MAMMOTOME BREAST BIOPSY. IT WAS REPORTED AFTER THE MICROMARK CLIP WAS DEPLOYED THE DOCTOR WAS REMOVING THE APPLIER. DURING THIS TIME, SHE WAS WITH THE APPLIER AND NOTICED SOMETHING WASN'T RIGHT WITH THE APPLIER TIP. AFTER TAKING A STEROTACTIC PAIR, SHE NOTICED THE METAL HUB OF THE APPLIER WAS IN THE BREAST. THERE WAS NO CONSEQUENCE TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other