BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSYS MARKER CLIP WITH INTRODUCER

    MDR report key: 200102 · Received December 1, 1998

    Report

    Report Number
    1527736-1998-03806
    Event Type
    Malfunction
    Date Received
    December 1, 1998
    Date of Event
    November 6, 1998
    Report Date
    November 6, 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 THE DEVICE WAS USED DURING A BREAST BIOPSY. IT WAS REPORTED THE SLEEVE OF THE C1530 MICROMARK CLIP APPLIER SHEARED OFF IN THE PT'S BREAST AFTER APPLICATION OF THE MICROMARK CLIP. THE REP IS FOLLOWING UP FOR FURTHER INFO.

    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