BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMRI REGISTRATION MATRIX FOR GE HEADHOLDER

    MDR report key: 3131128 · Received May 22, 2013

    Report

    Report Number
    8043933-2013-00016
    Event Type
    Other
    Date Received
    May 22, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAS BEEN NO EVENT REPORTED TO BRAINLAB BY ANY HOSPITAL REGARDING THIS SPECIFIC ISSUE. INITIAL REPORTER IS MFR, SINCE BRAINLAB DETECTED THIS ISSUE INTERNALLY. BRAINLAB CONCLUSION: ALTHOUGH THERE HAS BEEN NO PT INJURY NOR ANY ADVERSE EVENT REPORTED TO BRAINLAB BY ANY HOSPITAL REGARDING THIS SPECIFIC ISSUE, A RISK TO PT HEALTH CANNOT BE EXCLUDED. THE POTENTIAL ROTATIONAL MOVEMENT IS CAUSED BY THE SIZE AND TOLERANCE OF THE MOUNTING INTERFACES OF THE IMRI REGISTRATION MATRIX FOR GE HEADHOLDER, RESULTING IN THE FIXATION TO THE GE HEADHOLDER POSSIBLY NOT BEING AS TIGHT AS DESIRED. FOR FURTHER DETAILS PLEASE REFER TO PRODUCT NOTIFICATION LETTER (B)(4). BRAINLAB INTENDS THE FOLLOWING CORRECTIVE ACTIONS (CONCLUDED ON (B)(4) 2013): EXISTING POTENTIALLY AFFECTED CUSTOMERS RECEIVE A PRODUCT NOTIFICATION LETTER; BRAINLAB WILL PROVIDE REVISED HARDWARE TO AFFECTED CUSTOMERS IN ORDER TO RESOLVE THIS ISSUE FOR THE IMRI REGISTRATION MATRIX FOR GE HEADHOLDER AFTER AVAILABILITY. TENTATIVELY PLANNED AVAILABILITY: (B)(6) 2013.

    Description of Event or Problem · 1

    THE BRAINLAB IMRI REGISTRATION MATRIX FOR G HEADHOLDER ENABLES AUTOMATIC REGISTRATION OF THE INTRA-OPERATIVE MRI IMAGES FROM THE GE SCANNER TO THE PT'S ANATOMY FOR NAVIGATION, AND AT THE SAME TIME HOLDS THE REFERENCE ARRAY USED BY THE NAVIGATION. BRAINLAB HAS INTERNALLY DETECTED THAT THE IMRI REGISTRATION MATRIX MIGHT NOT ENSURE FIXATION TO THE GE HEADHOLDER THAT IS AS RIGID AS REQUIRED FOR NAVIGATION WITH THE BRAINLAB CRANIAL NAVIGATION SYSTEM. DUE TO THIS ISSUE, AN UNNOTICED ROTATIONAL MOVEMENT OF THE IMRI REGISTRATION MATRIX, INCLUDING THE ATTACHED REFERENCE ARRAY, RELATIVE TO THE GE HEADHOLDER, AND THUS THE PT'S HEAD, MIGHT OCCUR DURING SURGERY. THIS EFFECT COULD POTENTIALLY ADD A SHIFT OF SEVERAL MILLIMETERS TO INSTRUMENT POSITIONS VIRTUALLY DISPLAYED BY THE NAVIGATION SYSTEM IN THE REGION OF INTEREST, COMPARED TO THE ACTUAL PT ANATOMY. IF THESE DEVIATIONS WOULD OCCUR DURING SURGERY AND ARE NOT DETECTED BY USER VERIFICATION OF NAVIGATION ACCURACY, A RISK TO PT'S HEALTH COULD NOT BE EXCLUDED. THERE HAS BEEN NO EVENT REPORTED TO BRAINLAB BY ANY HOSPITAL REGARDING THIS SPECIFIC ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227241 IMRI REGISTRATION MATRIX FOR GE HEADHOLDER IMAGE GUIDED SURGERY SYSTEM/STEROTAXIC HAW BRAINLAB AG 19202

    Patients

    Seq Age Sex Outcome Treatment
    1