BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUROS

    MDR report key: 1900710 · Received November 12, 2010

    Report

    Report Number
    1900710
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 12, 2010
    Manufacturer
    HOLOGIC
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    A RADIOLOGY PATIENT WAS UNDERGOING BREAST BIOPSY. THE PATIENT WAS PREPPED AND THE VACUUM-ASSISTED SUROS CORE NEEDLE WAS ADVANCED. IT WAS FELT TO NOT OBTAIN THE NEEDED TISSUE SAMPLE FOR THE BIOPSY WHICH SUGGESTED MALFUNCTION. THIS NEEDLE WAS REMOVED AND A SECOND, NEW NEEDLE WAS ADVANCED THROUGH THE SHEATH WHICH WAS ALREADY IN PLACE FROM THE FIRST NEEDLE PLACEMENT. MULTIPLE CORE BIOPSY SPECIMENS WERE THEN ABLE TO BE OBTAINED SUCCESSFULLY. THERE WAS NO PATIENT HARM OR IMPACT. THE PROCEDURE WAS COMPLETED WITH NO FURTHER EVENT. IN TALKING WITH THE INVOLVED RADIOLOGY TECH SHE STATED THE "ROTATING NEEDLE" WHICH IS USED TO BIOPSY THE TISSUE WOULD NOT ROTATE TO CUT THE TISSUE. NO INJURY TO PATIENT, REPLACEMENT DEVICE OF SAME TYPE/MODEL WORKED AS EXPECTED.====================== HEALTH PROFESSIONAL'S IMPRESSION======================DID NOT PERFORM AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUROS SUROS EVIVA ATEC BIOPSY AND EXCISION SYSTEM KNW HOLOGIC EVIVA 0913-20 009022

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR