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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 Consequences Or Impact To Patient (2199)
Event Date 04/27/2019
Event Type  Injury  
Manufacturer Narrative
Outcomes to adverse event, type of reportable event: a risk to the patient's health could not be excluded for these specific circumstances, since biopsy paths were applied in a different location in the brain than intended, with the brainlab device involved, despite according to the surgeon: the final outcome of the surgery was successful (when the expected tissue samples could not be obtained at the two initial passes, the surgeon extended the burr hole to a small craniotomy and extracted the cyst with aid of navigation at the same surgery). There was no harm to a critical structure due to the unsuccessful passes. There were no negative clinical effects to the patient reported due to this issue. There were no further remedial actions reported that would have been necessary, done, or planned for this patient, nor was a prolongation of hospitalization reported. 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 biopsy paths compared to the intended path by less than 1 cm, is a combination of the following: a less than ideal point acquisition by the user during patient registration (e. G. Minimal registration points in the region of interest), may have caused 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. A less than ideal assembly of the frameless biopsy system may have led to potential bending of the bendable biopsy needle thereby leading to an inaccurate tracking by the brainlab cranial navigation software, and deviated path placement. Further contributing factor: no new ndi drms used for unsterile equipment, which might lead to deviation in positioning information displayed by navigation. Additional factor related to patient anatomy/ cyst structure: the cyst may have additionally deformed and may not have allowed an easy penetration of the biopsy needle. It is also possible (depending on where the planned trajectory was supposed to penetrate, mainly at the edge of the cyst) that the needle 'slipped off', leading to an inconclusive biopsy/ deviated path. Apparently the deviation has not been recognized by the user (prior to performing the biopsies) with the necessary continued verification of accuracy throughout the procedure. 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. Remedial action initiated: brainlab intends to re-iterate the relevant topics regarding the use of the device to this customer.
 
Event Description
A cranial surgery for extraction of a cranial cyst has been performed with the aid of brainlab navigation version 3. 1. 0 ((b)(6) 2019). The cyst was located in the left occipital region, about 3 cm from the surface coronal and 7. 5 cm sagittal, its diameter was about 2. 5 cm, and it had a volume of 16 cc. A pre-operative mri scan was acquired 2 days prior to the surgery, to use with navigation, and the cyst had been outlined by the surgeon. During the procedure the surgeon: positioned the patient in a lateral orientation and attached the 4-sphere standard reference array for navigation. Performed the initial patient registration on the pre-operative mri scan (surface matching using softouch and z-touch) to match the display of the navigation to the current patient anatomy. Verified the accuracy of the registration and judged it as very good. Planned position of the burr hole with aid of navigation (pointer). Assembled and setup the brainlab frameless biopsy system and aligned it roughly to the intended location. Planned a trajectory (with offset enabled; offset length was not transferred to the biopsy needle using a stopper, since the cyst was quite large). Had issues inserting the brainlab-distributed (pajunk) biopsy needle into the biopsy tube, and therefore loosened the tube inserts. Performed the biopsy, and detected that the tissue samples obtained did not contain the expected cystic lesion. Checked instrumentation, verified accuracy of registration and judged it acceptable. Performed another pass, but again could not obtain the expected samples. Decided to extend the burr hole to a small craniotomy. Verified registration accuracy again and judged it acceptable. Found the cyst with aid of navigation and extracted the cyst (deviation was approximated to be less than 1 cm). According to the hospital/surgeon: the final outcome of the surgery was successful (when the expected tissue samples could not be obtained at the two initial passes, the surgeon extended the burr hole to a small craniotomy and extracted the cyst with aid of navigation at the same surgery). There was no harm to a critical structure due to the unsuccessful passes. There were no negative clinical effects to the patient reported due to this issue. There were no further remedial actions reported that would have been necessary, done, or planned for this patient, nor was a prolongation of hospitalization reported.
 
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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
MDR Report Key8611249
MDR Text Key145112756
Report Number8043933-2019-00022
Device Sequence Number1
Product Code HAW
UDI-Device Identifier04056481132439
UDI-Public04056481132439
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 04/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2019
Is this an Adverse Event Report? Yes
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 Received04/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2015
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: 05/15/2019 Patient Sequence Number: 1
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