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

Model Number 22216-01A

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Weakness (2145)

Event Date 06/04/2019

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 instrument paths and tissue resections 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: the outcome of the surgery was successful in that the second biopsy samples yielded pathological tissue for diagnosis, but there was not as much as expected or desired.The patient presented negative symptoms after the surgery.The patient had a weakness on the left side.It is currently not known if the weakness will be permanent.It is not known if the weakness was caused by the removal of healthy tissue or if it is just an after-effect of the surgery.There was no negative effect for the patient due to the prolonged anesthesia of ca.3 hours.There were no further remedial/medical actions necessary, done, or planned for this patient.The surgeon does not intend to perform an additional biopsy.Hospitalization was prolonged by 1 day due to the patient's weakness on the left side.Apparently the deviation has not been recognized (prior to performing the biopsy) by the user with the necessary continued verification of accuracy after draping and throughout the procedure.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.Remedial action initiated: brainlab intends to reiterate the relevant topics regarding the use of the device to this customer.

Event Description

What is the issue? a cranial surgery for biopsy (diagnostic sample only) of a brain tumor in the right side of the brain 7cm deep with a size of ca.1 cm in diameter, was performed with the aid of the brainlab navigation software cranial navigation 3.1.Pre-operative mri scans were acquired on may 24, 2019, to use with navigation.During the procedure the surgeon: planned a trajectory on the pre-operative mri using the brainlab trajectory element.Positioned the patient in a supine orientation on the or table in a non-brainlab head-holder, and the brainlab reference array was attached.Performed the initial patient registration on the pre-op mri using the softouch and z-touch acquiring registration points on the patient's skin to match the display of the navigation to the current patient anatomy, and verified the accuracy of the registration and accepted the registration to proceed.Aligned the varioguide to the preplanned trajectory and inserted a 3rd party drill guide to the varioguide to create the burr hole.The surgeon used the brainlab-distributed biopsy needle to collect 4-6 samples via 1 pass, which were sent to pathology for diagnosis.Determined via the results of the pathology frozen section that only healthy tissue and no pathological tissue was biopsied.Performed an intraoperative mri, which was fused to the pre-op mri and plan; this showed a deviation of the actual trajectory from the planned trajectory by ca.7mm medial and superior.Performed a second patient registration on the mri using the softouch and z-touch acquiring registration points on the patient's skin to match the display of the navigation to the current patient anatomy, and verified the accuracy of the registration and accepted the registration to proceed.Aligned the varioguide and 3rd party drill guide to the planned trajectory and created a new burr hole, and collected 8 samples via 1 pass with the brainlab-distributed biopsy needle.Sent the samples to pathology who returned results showing the samples contained 50% pathological tissue and 50% normal tissue.Completed the surgery and performed a post-operative ct which showed the second trajectory still deviated from the planned trajectory and was not in the center of the tumor as intended.The patient presented negative symptoms after surgery: the patient had a weakness on left side (tissue was removed from right thalamus).According to the surgeon: the outcome of the surgery was successful in that the second biopsy samples yielded pathological tissue for diagnosis, but there was not as much as expected or desired.The patient presented negative symptoms after the surgery.The patient had a weakness on the left side.It is currently not known if the weakness will be permanent.It is not known if the weakness was caused by the removal of healthy tissue or if it is just an after-effect of the surgery.There was no negative effect for the patient due to the prolonged anesthesia of ca.3 hours.There were no further remedial/medical actions necessary, done, or planned for this patient.The surgeon does not intend to perform an additional biopsy.Hospitalization was prolonged by 1 day due to the patient's weakness on the left side.

• Brand Name: CRANIAL NAVIGATION SOFTWARE (VERSION 3.1)
• Type of Device: IMAGE 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: maura boyle ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 8750608
• MDR Text Key: 149763231
• Report Number: 8043933-2019-00034
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481000479
• UDI-Public: 04056481000479
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092467
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22216-01A
• Device Catalogue Number: 22216B
• Device Lot Number: SW V. 3.1.3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other