BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONOPTY BIOPSY SYSTEM

    MDR report key: 2624748 · Received May 13, 2009

    Report

    Report Number
    2624748
    Event Type
    Injury
    Date Received
    May 13, 2009
    Date of Event
    April 28, 2009
    Report Date
    May 13, 2009
    Manufacturer
    RADI MEDICAL SYSTEMS AB
    Product Code
    GAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING A PERCUTANEOUS LEFT ILIAC BONEBIOPSY WITH CT GUIDANCE. AS NEEDLE WAS BEING ADVANCED INTO LESION BY THE PHYSICIAN THE BONOPTY BONE BIOPSY SYSTEM NEEDLE FRACTURED. CT IMAGES REVEALED THAT THE NEEDLE WAS PARTIALLY IN THE BONE AND THE SURROUNDING TISSUE. THE PROCEDURE WAS STOPPED AFTER CONSULTING RADIOLOGIST TO SEE IF THERE WAS ANY WAY TO RETRIEVE THE NEEDLE. THE PT WAS UNDER CONSCIOUS SEDATION AT THE TIME. IN HOLDING AREA AFTER PT MORE AWAKE, PT AND FAMILY WERE NOTIFIED OF WHAT HAD OCCURRED. THE PTS REFERRING PHYSICIAN WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONOPTY BIOPSY SYSTEM BIOPSY NEEDLE GAA RADI MEDICAL SYSTEMS AB

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention