BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAINLAB SURGICAL NAVIGATION

    MDR report key: 3811963 · Received May 9, 2014

    Report

    Report Number
    3811963
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    December 12, 2013
    Report Date
    February 25, 2014
    Manufacturer
    BRAINLAB, INC
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A STEREOTACTIC BRAIN BIOPSY WAS CONDUCTED. HOWEVER, AFTER THE PROCEDURE WAS FINISHED, THE PHYSICIAN NOTED THAT THE BRAIN TUMOR WAS MISSED. THE PATIENT HAD TO RETURN TO HAVE A REPEAT PROCEDURE. THIS HAS HAPPENED ON MORE THAN ONE OCCASION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281302 BRAINLAB SURGICAL NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW BRAINLAB, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *