BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSY MARKER CLIP WITH INTRODUCER

    MDR report key: 200086 · Received December 1, 1998

    Report

    Report Number
    1527736-1998-03808
    Event Type
    Malfunction
    Date Received
    December 1, 1998
    Date of Event
    November 4, 1998
    Report Date
    November 4, 1998
    Manufacturer
    BIOPSYS MEDICAL, INC
    Product Code
    KNW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE RADIOLOGIST THE DEVICE WAS USED DURING A BREAST BIOPSY. IT WAS REPORTED THE CLIP WAS DEPLOYED AND THE MARKER SLEEVE OF THE ULTEM TUBE WAS SHEARED OFF. 11/10/1998 THE SHEARED OFF MARKER SLEEVE REMAINED IN THE BREAST TISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other