BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEKTA

    MDR report key: 202440 · Received December 15, 1998

    Report

    Report Number
    202440
    Event Type
    Injury
    Date Received
    December 15, 1998
    Date of Event
    March 17, 1998
    Report Date
    November 23, 1998
    Manufacturer
    ELEKTA INSTRUMENTS, INC.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER THE PT WAS INTUBATED, POSITIONED PRONE ON THE MAGNETIC RESONANCE IMAGING TABLE AND SCANNED, THE WAND GUIDED STERIOTACTIC BIOPSY PROCEDURE WAS PREFORMED. FOLLOWING CLOSURE, THE PT WAS COMPUTER AXIAL TOMOGRAPHY SCANNED, WITH A SMALL REMNANT OF THE TITANIUM BIOPSY PROBE NOTED TO BE PRESENT. SURGERY WAS NEEDED TO REMOVE REMNANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELEKTA TITANIUM BIOPSY NEEDLE WITH 2.5X10MM OPENING KNW ELEKTA INSTRUMENTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention