BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROMARK CLIP

    MDR report key: 105292 · Received July 8, 1997

    Report

    Report Number
    2030611-1997-00001
    Event Type
    Injury
    Date Received
    July 8, 1997
    Date of Event
    June 10, 1997
    Report Date
    July 8, 1997
    Manufacturer
    BIOPSYS MEDICAL, INC.
    Product Code
    GAG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THAT FOLLOWING THE BREAST BIOPSY, TRIED TO DEPLOY THE MICROMARK. THE MICROMARK WAS INSERTED INTO THE MAMMOTOME PROBE WITHOUT DIFFICULITY AND DEPLOYED. UPON REMOVAL OF THE MICROMARK FROM THE PROBE, IT WAS NOTED THAT THE STAPLE HAD NOT DEPLOYED AND THE INTRODUCER WAS MISSING THE DISTAL TIP. AN ATTEMPT WAS MADE TO REMOVE THE INTRODUCER DISTAL TIP FROM THE BREAST; THIS WAS ATTEMPTED WITH TWEEZERS UNDER THE SKIN IN THE INCISION. THIS ATTEMPT FAILED TO RETRIEVE THE DISTAL TIP. AN ULTRASOUND EXAMINATION WAS PERFORMED AND THE DISTAL TIP WAS IDENTIFIED. A LOCALIZATION WIRE WAS PLACED AND THE PT UNDERWENT A SURGICAL EXCISION OF DISTAL TIP. THE PT TOLERATED THE PROCEDURE WELL WITHOUT ANY FURTHER SEQUELA. THE PRODUCT AND THE DISTAL TIP RETRIEVED FROM THE PT WERE RETURNED AND EVAL. PHYSICAL EXAMINATION OF THE INTRODUCER REVEALED WHAT APPEARED TO BE A STRETCHING OF THE TUBING (APPROX 1/8" LENGTH) AND A LACERATION (3/16" LENGTH). THE DISTAL TIP WAS INTACT WITH THE PROXIMAL TUBING APPEARING STRETCHED (APPROX 1/8" LENGTH) AND A LACERATION (3/16" LENGTH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROMARK CLIP SOFT TISSUE STAPLE GAG BIOPSYS MEDICAL, INC. BMI-1530 W3133

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention MAMMOTOME| BREAST BIOPSY SYSTEM