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U.S. Department of Health and Human Services

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

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BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 3.1) MAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 22216-02
Device Problem Use of Device Problem (1670)
Patient Problems Muscle Weakness (1967); Brain Injury (2219)
Event Date 01/06/2022
Event Type  Injury  
Event Description
A cranial surgery for resection of a tumor, located ca. 25mm deep in the parietal lobe in the brain, with a size of ca. 3. 2ccm, has been performed with the aid of the brainlab navigation sw cranial 3. 1. A pre-operative mri scan acquired 10 days before the surgery was used to reference the navigation display to. During the procedure the surgeon: positioned the patient in a supine orientation in a non-brainlab head holder, and attached the patient reference array for navigation to the head holder. Performed the initial patient registration on the pre-op mri acquiring registration points on the patient's head skin with the softouch pointer to match the display of the navigation to the current patient anatomy. Verified the accuracy, and after planning out the skin incision and tumor region with the softouch, suspected that the navigation display is not as accurate as desired, decided to perform a new patient registration to navigation. Verified the accuracy of the new patient registration to navigation, and accepted the registration to proceed. Determined the entry point into the head with the navigated pointer, as well as the tumor outline, and marked these on the patient's skin. Draped the patient and exchanged the reference array to a sterile one. Performed the incision at the planned location, and again used the navigated pointer to map out the tumor outline for the craniotomy (bone flap), and created the bone flap of ca. 5x3cm in the skull. Used the navigated pointer for instrument guidance for the path to the lesion and to resect suspected tumor tissue. When the patient's neuromonitoring motor potentials decreased dramatically, suspected that the path and resections in the brain performed were deviating from the intended locations. Correspondingly discontinued the tumor resection and concluded the surgery once the motor potentials dropped. Closed the patient without the tumor resected at this surgery. A post-op mri scan showed that the dissection path deviated by ca. 1cm posterior to the intended path in the brain, and brain tissue was resected directly posterior to the tumor. As per the surgeon, the deviation affected the motor strip in the brain, and the negative effect to the patient is an increased motor weakness. A further surgery necessary due to very poor wound healing of the patient- unrelated to the use of the brainlab navigation and the deviating re-/dissections in the brain - took place on (b)(6) 2022. This surgery was used as an opportunity to also resect the tumor as was originally intended. The tumor resection revision part of this surgery also with the aid of brainlab navigation, and using the same bone flap (craniotomy) from the original surgery, was successful as intended. According to the surgeon (treating clinician): an inaccuracy of the navigation display (leading to a deviating path and resections in the brain) was suspected when the patient's neuromonitoring motor potentials decreased dramatically. The tumor resection surgery was correspondingly discontinued and concluded once the motor potentials dropped. The tumor was not resected at this surgery. The deviation of the re-/dissections affected the motor strip in the patient's brain, and the negative effect to the patient is an increased motor weakness, which is still present, although has partially improved since the additional surgery. The additional surgery on (b)(6) 2022 to address unrelated poor wound healing of the patient, was used as an opportunity to also resect the tumor as was originally intended. The tumor resection revision part of this additional surgery, using the same bone flap (craniotomy) from the original surgery, was successful as intended. There were no further negative effects to the patient due to prolong of the original surgery and anesthesia of ca. 15min, also not due to the additional surgery/anesthesia of ca. 90min that as a part included the tumor resection revision. There were further no remedial actions reported necessary, done or planned for this patient due to the deviating dissections and resections in the brain - hospitalization was also not prolonged due to these. Despite hospitalization was prolonged for this patient, this was because of additional therapy for the patient's poor wound healing unrelated to the use of the brainlab navigation.
 
Manufacturer Narrative
A risk to the patient's health could not be excluded for these specific circumstances, since a different path and resections in the brain were performed other than anticipated and intended with the brainlab navigation involved, affecting the motor strip and resulting in increased motor weakness of the patient, which is still present, although according to the surgeon: an inaccuracy of the navigation display (leading to a deviating path and resections in the brain) was suspected when the patient's neuromonitoring motor potentials decreased dramatically. The tumor resection surgery was correspondingly discontinued and concluded once the motor potentials dropped. The tumor was not resected at this surgery. The deviation of the re-/dissections affected the motor strip in the patient's brain, and the negative effect to the patient is an increased motor weakness, which is still present, although has partially improved since the additional surgery. The additional surgery on (b)(6) 2022 to address unrelated poor wound healing of the patient, was used as an opportunity to also resect the tumor as was originally intended. The tumor resection revision part of this additional surgery, using the same bone flap (craniotomy) from the original surgery, was successful as intended. There were no further negative effects to the patient due to prolong of the original surgery and anesthesia of ca. 15min, also not due to the additional surgery/anesthesia of ca. 90min that as a part included the tumor resection revision. There were further no remedial actions reported necessary, done or planned for this patient due to the deviating dissections and resections in the brain - hospitalization was also not prolonged due to these. Despite hospitalization was prolonged for this patient, this was because of additional therapy for the patient's poor wound healing unrelated to the use of the brainlab navigation. 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 tumor resection and path deviating by ca. 1cm posterior to the intended location is: an inadequate patient mri scan used for registration in combination with an insufficient distribution of points acquired by the user for patient anatomy registration to navigation, both not following brainlab requirements. Specifically, the scan used did not have a distortion correction filter enabled and contained significant distortion/artifacts around the eyes. The surface matching points were not equally distributed on both sides of the patient's face and did not include the region of interest, and bony areas e. G. Around the eyes (likely due to the visible artifacts). This caused the navigation software to not find an as accurate match as desired in the region of interest for this specific procedure, between the preoperative image dataset and actual patient anatomy. An additional minor factor that to a much lesser extent might have contributed to the deviation was the possible use of damaged navigation reference arrays (1 unsterile, and 1 sterile) which were identified to have bent marker pins by the brainlab representative during hardware testing at this site performed after the surgery. Despite not knowing exactly when the damage occurred and if either or both of these instruments were used at this specific procedure, the potential use of these damaged instruments at this surgery cannot be excluded as a possible factor. The instrument damage on both arrays likely occurred through improper handling at the user site, which apparently was not detected by the user after the damage occurred. The navigation software relies on the recognition of an exact same position and geometry of the navigation reference array in relation to the patient anatomy as it was during registration to navigation based on the pre-operative scan to the current patient anatomy, throughout the complete use of navigation during a surgery, in order to accurately track navigated instruments. Apparently, the resulting deviation of the navigation display was not recognized by the user with the required thorough verification of the registration accuracy, and the necessary continued verification of navigation accuracy after registration, after draping, and throughout the procedure (prior to making the incision). 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. In addition, the navigation reference arrays found damaged have already been removed from clinical use at this specific site.
 
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Brand NameCRANIAL NAVIGATION SOFTWARE (VERSION 3.1)
Type of DeviceMAGE 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 Key13692172
MDR Text Key286917894
Report Number8043933-2022-00013
Device Sequence Number1
Product Code HAW
UDI-Device Identifier04056481132439
UDI-Public04056481132439
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192703
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number22216-02
Device Catalogue Number22216A
Device Lot NumberSW V. 3.1.0
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2016
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: 03/08/2022 Patient Sequence Number: 1
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