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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); Device Handling Problem (3265)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/07/2016
Event Type  No Answer Provided  
Manufacturer Narrative
A risk to the patient's health could not be excluded for these specific circumstances, since a tissue sample was obtained in another location than intended, with the brainlab device involved, although: there is no indication of a systematic error or malfunction of the brainlab device. Corresponding measures to minimize this anticipated risk as low as reasonably practicable are already in place. According to the hospital, the tumor was completely resected, there were no negative clinical effects for this specific patient due to this issue, and no remedial actions were necessary, done or planned for this patient due to this issue. 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 tissue sample obtained in another location than intended is a combination of the following factors: inappropriate quality of the mr patient image data that were used for navigation (they were not performed according to the brainlab scan protocol and showed motion artefacts and distortion) resulting in a bad quality of image fusion and thus leading to a deviation of displayed data in navigation and actual patient anatomy. Brain tissue may have shifted in the anterior/posterior direction due to an air bubble/pocket near the tumor (as was stated by the surgeon), leading to a decreased navigation accuracy. Since the inappropriate quality of mr patient image data did not allow for appropriate verification of registration accuracy, the less than ideal image fusion and brain shift apparently was not detected (despite verification having been performed). There is no indication of a systematic error or malfunction of the brainlab navigation device. Corresponding brainlab measures to minimize this anticipated risk as low as reasonably practicable are already in place. Brainlab intends to: inform this hospital about the investigation results corresponding to the root cause, brainlab intends to re-iterate the relevant topics regarding the use of the device to this customer.
 
Event Description
A cranial surgery for tumor resection (right parietal lobe, near cortical surface, size 10-11mm) was performed with the aid of the brainlab cranial 3. 1 navigation software. During the procedures the surgeon: positioned the patient in supine position. Registered the actual patient anatomy to the navigation (to the pre-operative image imported into and used by the navigation system). Verified and accepted the patient registration in the navigation. Planned incision with the aid of navigation. Prepared and draped the patient and exchanged the unsterile reference array for a sterile one. Verified the patient registration and determined it good. Exposed to region of interest (just below dura at cortical surface) and did not see the tumor. Verified the patient registration again and determined accuracy as good laterally, but found it difficult to verify accuracy in the anterior/posterior axis. Obtained a tissue sample and send it to pathology; the sample was confirmed to be healthy brain tissue. Closed the wound temporarily (without bone flap), acquired a ct image, and determined that the tumor was posterior (5-7mm) to where the sample was taken. Completed tumor resection without aid of navigation (the tumor was still within the craniotomy, there was no need to enlarge the craniotomy). According to the hospital, the tumor was completely resected, there were no negative clinical effects for this specific patient due to this issue, and no remedial actions were necessary, done or planned for this patient due to this issue.
 
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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
andrea miller
olof-palme-strasse 9
münchen, 81829
GM   81829
89 9915680
MDR Report Key6217994
MDR Text Key63716977
Report Number8043933-2017-00001
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 12/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number22216A
Device Catalogue Number71202A
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 Received12/07/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/25/2015
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: 01/03/2017 Patient Sequence Number: 1
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