BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPLAN STEREOTAXY PLANNING SOFTWARE

    MDR report key: 1860099 · Received September 21, 2010

    Report

    Report Number
    8043933-2010-00013
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    May 4, 2010
    Report Date
    September 2, 2010
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    PMA / PMN Number
    K053127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DESPITE THERE WAS NO ADVERSE EVENT OR ANY PT INJURY REPORTED BY THIS OR ANY OTHER HOSPITAL, A RISK TO PT HEALTH COULD NOT BE EXCLUDED. BRAINLAB'S INVESTIGATION HAS SHOWN THAT THE TARGET POINT OFFSET RELATIVE TO THE AC OR PC POINT MIGHT BE INCORRECT ON THE TREATMENT PLAN PRINTOUT DUE TO A SOFTWARE ERROR WITHIN THE IPLAN STEREOTAXY PLANNING SOFTWARE VERSIONS 3.0.0 OR 3.0.1. THIS OFFSET IS ONLY PROVIDED AS ADDITIONAL INFORMATION AND IS NOT USED FOR ALIGNING THE STEREOTACTIC ARC. NEVERTHELESS, IT MAY BE USED FOR MAKING CLINICAL DECISIONS, WHICH DUE TO THE ERRONEOUS PRINTOUT COULD BE INCORRECT. BRAINLAB INTENDS THE FOLLOWING CORRECTIVE ACTIONS: POTENTIALLY AFFECTED CUSTOMERS RECEIVE A PRODUCT NOTIFICATION INFORMATION. POTENTIALLY AFFECTED CUSTOMERS WILL RECEIVE A SOFTWARE UPDATE TO CORRECT FOR THIS SOFTWARE ERROR. TENTATIVELY PLANNED AVAILABILITY: END OF OCTOBER 2010. BRAINLAB WILL ACTIVELY CONTACT POTENTIALLY AFFECTED CUSTOMERS TO IMPLEMENT THE SOFTWARE UPDATE UPON AVAILABILITY.

    Description of Event or Problem · 1

    THE USER PLANNED A TRAJECTORY INTO THE PT'S BRAIN WITH THE BRAINLAB IPLAN STEREOTAXY PLANNING SOFTWARE 3.0. AFTER ADDITIONALLY REFERENCING THE TARGET POINT RELATIVE TO THE AC OR THE PC POINT, THE USER NOTICED THAT THE TARGET POINT OFFSET WAS INCORRECT ON THE TREATMENT PLAN PRINTOUT. THE SOFTWARE CALCULATES, DISPLAYS AND PRINTS THE STEREOTACTIC ARC SETTINGS CORRECTLY ON THE SCREEN, AS WELL AS ON THE PRINTOUT. THESE SETTINGS ARE USED TO ALIGN THE PLANNED TRAJECTORY. DESPITE THERE WAS NO ADVERSE EVENT OR ANY PT INJURY REPORTED BY THIS OR ANY OTHER HOSPITAL, A RISK TO PT HEALTH COULD NOT BE EXCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPLAN STEREOTAXY PLANNING SOFTWARE PLANNING SYSTEM/STEREOTAXIC INSTRUMENT HAW BRAINLAB AG 3.0

    Patients

    Seq Age Sex Outcome Treatment
    1