BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSYS MARKER CLIP WITH INTRODUCER

    MDR report key: 206564 · Received January 13, 1999

    Report

    Report Number
    1527736-1999-00219
    Event Type
    Malfunction
    Date Received
    January 13, 1999
    Date of Event
    December 15, 1998
    Report Date
    December 15, 1998
    Manufacturer
    BIOPSYS MEDICAL, INC.
    Product Code
    KNW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY REP THAT THE DEVICE WAS USED DURING A STEREOTACTIC BREAST BIOPSY. IT WAS REPORTED THE SURGEON FOLLOWED ALL CLIP DEPLOYMENT STEPS CORRECTLY. WHEN HE WITHDREW THE INNER STYLET, IT SIMPLY PULLED ALL THE WAY OUT. THE METAL TIP WAS MISSING. HE DID NOT FEEL ANY RESISTANCE WHILE WITHDRAWING THE STYLET. HE REMOVED THE PURPLE INTRODUCER OF THE C1530 CLIP. THE PROBE WAS REMOVED AND TOOK A STEREO PAIR. THE TIP WAS VISIBLE ON STEREO PAIR. IT WAS LEFT IN PLACE IN THE BREAST TO SERVE AS A MARKER. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPSYS MARKER CLIP WITH INTRODUCER BIOPSYS KNW BIOPSYS MEDICAL, INC. NA W6824

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other