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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 2.1.2) IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

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BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 2.1.2) IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 22214C
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Patient Problems Facial Nerve Paralysis (1846); Memory Loss/Impairment (1958); Paresis (1998); Brain Injury (2219)
Event Date 01/09/2019
Event Type  Injury  
Manufacturer Narrative
A risk to the patient's health could not be excluded for these specific circumstances, since instrument paths were applied in a different location in the brain than anticipated, with the brainlab device involved, and negative clinical effects did occur for this patient according to the surgeon: despite the surgery was successful as intended: the tumor was found and the desired samples were resected as intended (only diagnostic tissue was obtained, there were no incorrect resections). Despite during the surgery there were no changes or corrections of any surgical steps, there was also no delay of the surgery or anesthesia. It was determined after the surgery from a post-op mri that the instruments' path had hit the patient's thalamus. The patient had a right hemiparesis and facial nerve palsy, and also a conductive aphasia and memory problems. The patient was given steroids to minimize potential swelling due to irritations by the path applied. The patient also had physical and speech therapy. There were no further remedial/medical actions done for this patient. The hemiparesis and facial palsy have largely improved. The other problems not yet. Hospitalization was prolonged by about 4 days (plus regular follow-up visits by the patient for the remaining issues). 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 deviation of the applied instrument path from the intended position by ca. 10mm is a combination of the following factors: a less than ideal point acquisition by the user during patient registration, not completely following the brainlab recommendations as required (e. G. No registration points in or around the region of interest were taken), causing the brainlab cranial navigation software to not find an as accurate match as desired in the region of interest for this specific biopsy procedure, between the preoperative image dataset and the actual patient anatomy. Apparently, the resulting deviation was not recognized by the user (prior to applying the instrument path) with the necessary accuracy verification of navigation throughout the procedure. The non-brainlab sheath, used as a guidance for the navigated brainlab stylet, had a diameter larger than what is recommended and specified compatible by brainlab for use with the brainlab stylet. This probably has led to the stylet bending during the procedure due to angulations, especially when exiting the sheath into the brain, when inside the patient anatomy. Bending of the stylet during the procedure can result in significant deviations compared to the navigation display, since this physical change of the instrument cannot be recognized by the navigation. Bending causes the actual tip position to differ from the navigation display. The non-brainlab endoscope, which was calibrated to the navigation using a less than ideal size adapter array, followed the same path as formerly created together by the brainlab stylet and non-brainlab guidance sheath. 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 surgery an extended endoscopic biopsy (for diagnostic tissue and tissue for the research lab) of a low grade glioma, located ca. 8cm deep in the temporal lobe of the brain, with size of ca. 22cm², has been performed with the aid of the brainlab navigation version 2. 1. 2. A pre-operative mri scan was acquired 2 days before the surgery, to use with navigation. A trajectory was planned on the mri scan. During the procedure, the surgeon: positioned the patient in a supine orientation in a non-brainlab head holder. Performed the initial patient registration on the pre-op mri acquiring registration points on the patient's skin to match the display of the navigation to the current patient anatomy. Verified the accuracy of the registration and accepted the registration to proceed. Removed the unsterile navigation reference array and draped the patient. Attached a sterile reference array, re-verified navigation accuracy, determined location of the burr hole for the desired approach with navigation, and created a single burr hole (craniotomy) to the planned trajectory. Attached a (non-brainlab) non-navigated adhesive introducer sheath at the burr hole entry to use as an instrument guidance. Used the navigated stylet to create a path to the tumor, introduced into the patient's brain through the non-brainlab sheath, aligning the stylet to the pre-planned trajectory. Fixated a navigation reference array to a rigid non-brainlab endoscope, and calibrated it to the navigation. Introduced this calibrated endoscope through the same adhesive sheath, aligning it to the pre-planned trajectory and following the created path in the brain to the tumor. Found the tumor, and successfully resected the desired samples as intended (only diagnostic tissue was obtained, there were no incorrect resections). Closed the patient and concluded the surgery. The patient presented negative symptoms after the surgery. From a post-op mri the surgeon determined that the actual path deviated ca. 10mm laterally from the planned trajectory navigated to (more medial was intended). The surgeon determined that the deviating instrument path had hit the thalamus of the patient. According to the surgeon: the surgery was successful as intended: the tumor was found and the desired samples were resected as intended (only diagnostic tissue was obtained, there were no incorrect resections). During the surgery, there were no changes or corrections of any surgical steps, there was also no delay of the surgery or anesthesia. - it was determined after the surgery from a post-op mri that the instruments' path had hit the patient's thalamus. The patient had a right hemiparesis and facial nerve palsy, and also a conductive aphasia and memory problems. The patient was given steroids to minimize potential swelling due to irritations by the path applied. The patient also had physical and speech therapy. There were no further remedial/medical actions done for this patient. The hemiparesis and facial palsy have largely improved. The other problems not yet. Hospitalization was prolonged by about 4 days (plus regular follow-up visits by the patient for the remaining issues).
 
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Brand NameCRANIAL NAVIGATION SOFTWARE (VERSION 2.1.2)
Type of DeviceIMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
BRAINLAB AG
olof-palme-strasse 9
muenchen, 81829
GM 81829
Manufacturer (Section G)
BRAINLAB AG
olof-palme-strasse 9
muenchen, 81829
GM 81829
Manufacturer Contact
markus hofmann
olof-palme-strasse 9
muenchen, 81829
GM   81829
MDR Report Key8334588
MDR Text Key135997454
Report Number8043933-2019-00003
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 01/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number22214C
Device Catalogue Number71208
Device Lot NumberSW V. 2.1.2
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 Received01/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2015
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: 02/13/2019 Patient Sequence Number: 1
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