BEUDAMED
    FDA Adverse Event Other Summary report: N

    BONOPTY BIOPSY SET

    MDR report key: 533002 · Received July 2, 2004

    Report

    Report Number
    8030904-2004-00002
    Event Type
    Other
    Date Received
    July 2, 2004
    Date of Event
    June 10, 2004
    Report Date
    July 2, 2004
    Manufacturer
    RADI MEDICAL SYSTEMS AB
    Product Code
    KNW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A SPINAL BIOPSY WAS BEING PERFORMED UNDER DIRECT CONSULTANT SUPERVISION FROM THE VERTEBRAL BODY OF L4. ASEPTIC TECHNIQUE WITH 1% LIDOCAINE USED FOR LOCAL ANAESTHESIA AND 1.5 MG OF IV MIDAZOLAM FOR SEDATION. THE BIOPSY NEEDLE HAD BEEN OPTIMALLY POSITIONED FOR THE BIOPSY AND THE CUTTING BIOPSY NEEDLE WAS BEING USED TO OBTAIN THE BIOPSY. THE BONE WAS TOUGH BUT SATISFACTORY NEEDLE PROGRESS THROUGH THE BONE WAS BEING MADE. HOWEVER, THE NEEDLE SHAFT SHEARED LEAVING BEHIND 3 TO 4 CM OF THE BIOPSY NEEDLE BEHIND. THE SHAFT BROKE IN THE SOFT TISSUES LYING POSTERIOR TO THE VERTEBRAL BODY, I.E. NOT AT THE BONE SURFACE. SINCE THE NEEDLE COULD NOT BE REMOVED THE PROCEDURE WAS ABANDONED, AND THE PT RETURNED TO THE WARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONOPTY BIOPSY SET NEEDLE, BIOPSY, SINGLE-USE KNW RADI MEDICAL SYSTEMS AB 10-1073 030730

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention BONOPTY PENETRATION SET, 10-1072, 1% LIDOCAINE.| 1.5 MG MIDAZOLAM.