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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 3.1) IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

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BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 3.1) IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 22216A
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/13/2017
Event Type  malfunction  
Manufacturer Narrative
A risk to the patient's health could not be excluded for these specific circumstances, since a laser fiber was placed in the brain in another location than intended with the brainlab device involved, despite according to the surgeon: no laser ablation of unintended (brain) tissue occurred. There were no negative effects to the patient, and there was no delay of the surgery due to this issue. There were no further actions done for this patient during the surgery due to this issue. There are no further remedial actions necessary, done of planned for this patient other than a routine 1 month mri follow-up. According to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the root cause for the trajectory/laser fiber placed in another location than intended with the aid of navigation, is that the patients anatomy (skin surface) was different in the pre-op mri used for registration to navigation compared to the actual skin surface at the surgery. This was due to the patient positioning at the surgery causing the skin of the face to move and change. The pre-op mri showing motion artefacts and not being appropriate for surface registration to the brainlab navigation. A further contributing factor is brain shift, with the brain anatomy being different in the ca. 1. 5 months old pre-op mri, compared to the brain anatomy during the laser fiber placement. There is no indication of a systematic error or malfunction of the brainlab device (navigation). Corresponding brainlab measures to minimize this anticipated risk as low as reasonably practicable are already in place. Brainlab intends to re-iterate the relevant topics regarding the use of the device to this customer.
 
Event Description
A cranial tumor laser ablation was performed with the aid of brainlab cranial navigation system 3. 1, for a lesion (melanoma metastasis) with a size of ca. 3. 5x2. 5cm, located in deep right occipital lobe. A pre-operative mri dataset was obtained for use at the surgery and with the aid of the navigation ca. 1. 5 months before the surgery. A trajectory was planned on the pre-op mri with the brainlab iplan planning software before the surgery. During the procedure the surgeon: positioned the patient in a lateral position with right side up in a (non-brainlab) head holder. Performed the initial patient registration (using surface matching with a combination of z-touch and softouch) to match the virtual display of preoperative mri scan to the current patient anatomy and verified the accuracy of registration with a satisfying result. Aligned the brainlab varioguide with the aid of navigation to the intended trajectory, made the burrhole into the patient's skull, and inserted the probe. Performed an intra-operative mri after placement of probe before ablation, and determined that the actual entry point of the probe's trajectory was ca. 9mm medial to planned entry point, the actual target point ca. 3mm medial to planned target. Decided to continue with the surgery (laser ablation) with the current placement of the laser probe. Performed the laser ablation of the lesion, with some of the area of enhancement not treatable with the actual laser position. According to the surgeon: no laser ablation of unintended (brain) tissue occurred. There were no negative effects to the patient, and there was no delay of the surgery due to this issue. There were no further actions done for this patient during the surgery due to this issue. There are no further remedial actions necessary, done of planned for this patient other than a routine 1 month mri follow-up.
 
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Brand NameCRANIAL NAVIGATION SOFTWARE (VERSION 3.1)
Type of DeviceIMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
BRAINLAB AG
olof-palme-strasse 9
münchen, 81829
GM 81829
Manufacturer (Section G)
BRAINLAB AG
olof-palme-strasse 9
münchen, 81829
GM 81829
Manufacturer Contact
markus hofmann
olof-palme-strasse 9
münchen, 81829
GM   81829
89 9915680
MDR Report Key6331367
MDR Text Key67443050
Report Number8043933-2017-00003
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092467
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 01/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number22216A
Device Catalogue Number71205
Device Lot NumberSW V. 3.1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/08/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/15/2017 Patient Sequence Number: 1
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