BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSYS MICROMARK II

    MDR report key: 202363 · Received December 15, 1998

    Report

    Report Number
    1527736-1998-04200
    Event Type
    Malfunction
    Date Received
    December 15, 1998
    Date of Event
    December 7, 1998
    Report Date
    December 7, 1998
    Manufacturer
    BIOPSYS MEDICAL, INC.
    Product Code
    KNW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE WAS USED DURING A BREAST BIOPSY. IT WAS REPORTED THE MLCROMARK CLIP WAS DEPLOYED AND THE TIP OF THE INTRODUCER HUB STAYED IN THE BREAST. THE TIP CAME OUT WITH THE "PURPLE SHEATH". THERE WAS NO CONSEQUENCE TO THE PATIENT. THE PROBE WAS A P1155.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPSYS MICROMARK II BIOPSYS KNW BIOPSYS MEDICAL, INC. NA W6029

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other