BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSYS

    MDR report key: 185311 · Received September 1, 1998

    Report

    Report Number
    185311
    Event Type
    Malfunction
    Date Received
    September 1, 1998
    Date of Event
    August 5, 1998
    Report Date
    August 26, 1998
    Manufacturer
    BIOPSYS MEDICAL INC
    Product Code
    MIJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING STEREOTACTIC BIOPSY, WHEN CLIP WAS DEPLOYED PUSHER PIN WAS ALSO DEPLOYED EMBEDDED W/ CLIP. NOT REMOVED. PHYSICIAN REPORTS NO PROBABLE DAMAGE TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPSYS MICRO-MARK CLIP MIJ BIOPSYS MEDICAL INC BMI 1530 W6432

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other