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

Model Number	22216-01A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A risk to the patient's health could not be excluded for these specific circumstances, since instrument paths and a tissue resection were applied in a different location in the brain than anticipated, with the brainlab device involved, despite according to the hospital: the surgery was to retrieve a diagnostic sample, not to remove or treat the lesion, and was completed successfully as intended, with the desired diagnostic sample retrieved.There was no harm or negative effect to the patient due to the biopsy and there was no prolong of surgery/anesthesia time.There was no (direct or increased) risk to harm a critical brain structure (e.G.Blood vessels or important brain tissue) due to an actual biopsy resection or path actually applied.There are no remedial actions necessary, done or planned for this patient.Hospitalization was not prolonged either.According to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the root cause of the deviation of the biopsy path by approximately 1.75 mm from the planned trajectory, resulting in a mixed biopsy sample (of pathogenic and unanticipated normal brain tissue), was due to a combination of the following factors: a movement of the patient reference array and/or movement of the patient's head within the head holder during the procedure due to an insufficient rigid fixation and/or inadvertently applied forces after registration.A movement of the patient reference relative to the patient's head (or vice versa) cannot be recognized by the navigation software and can result in an inaccurate display of tracked instruments on the registered (pre-operative) patient image.A suboptimal patient scan used to register the patient and a suboptimal distribution of points acquired by the user on the patient's skin for registration, both of which did not completely follow brainlab's recommendations and can cause the software to find a match that is not as accurate as desired between the pre-operative patient image and the actual patient anatomy for the procedure: artifacts and skin shift were present in the scan at the skin threshold set by the user for registration, not enough registration points were taken down either side of the patient's nose, points were taken in scan areas where artifacts were present, and points were taken in areas of potential skin shift.Overall, the deviation of approximately 1.75 mm reported by the surgeon is within their own reported expectations of between 1 to 2 mm for this procedure from the navigation system, and is within use specifications (expectable system accuracy) of the brainlab cranial navigation software, but apparently exceeded the surgeon's clinically desired limits for this specific intended target point.Apparently the resulting deviation between the displayed navigation information and the actual patient anatomy was not detected before the biopsy with the necessary continuous accuracy verification by the user.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 reiterate the relevant topics regarding the use of the device to this customer.
Event or Problem Description
A cranial surgery for diagnostic biopsy of a spherical lesion approximately 11mm in diameter located in the right side of the brain, was performed with the aid of the display by the brainlab navigation software cranial (b)(6) a preoperative mri scan was acquired five days prior to the surgery, to use with navigation.During the procedure the surgeon: positioned the patient in lateral position in a non-brainlab headholder.Performed the initial patient registration on the preoperative mri using the softouch 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, and re-verified navigation accuracy with the sterile pointer.Attached the varioguide and aligned it to a pre-planned trajectory previously created in the navigation software.Drilled a burr hole using the varioguide drill kit to align the drill to the intended entry point.Passed the brainlab-distributed biopsy needle through the varioguide along the planned trajectory to collect a tissue sample.Sent the tissue sample to pathology, who determined the sample contained a mixture of diagnostic (pathogenic) and healthy tissue.Completed the surgery.A post-operative ct was performed which showed that the actual trajectory of the biopsy needle and location of the tissue sample deviated approximately 1.75mm in the posterior and caudal directions from the intended position (at both the entry and target points).According to the hospital: the surgery was to retrieve a diagnostic sample, not to remove or treat the lesion, and was completed successfully as intended, with the desired diagnostic sample retrieved.There was no harm or negative effect to the patient due to the biopsy and there was no prolong of surgery/anesthesia time.There was no (direct or increased) risk to harm a critical brain structure (e.G.Blood vessels or important brain tissue) due to an actual biopsy resection or path actually applied.There are no remedial actions necessary, done or planned for this patient.Hospitalization was not prolonged either.

• Brand Name: CRANIAL NAVIGATION SOFTWARE (VERSION 3.1)
• Common Device Name: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 10421283
• Report Number: 8043933-2020-00041
• Device Sequence Number: 14219479
• Product Code: HAW
• UDI-Device Identifier: 04056481000479
• UDI-Public: 04056481000479
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092467
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 22216-01A
• Device Catalogue Number: 71202A
• Device Lot Number: SW V. 3.1.3.
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other