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

Model Number 22216-02B

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

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 06/12/2020

Event Type  Injury  

Manufacturer Narrative

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 there were negative clinical effects for the patient, according to the surgeon: despite the outcome of the revision surgery using the same brainlab navigation equipment was successful as intended.Despite there are no further remedial actions necessary, done, or planned for this patient.The patient experienced a slight increase in agnosia, and according to the surgeon the agnosia was due to the entry caudal and dorsal to the intended target.It is not known whether the patient's agnosia is reversible or permanent.The patient also experienced some left facial weakness following the revision surgery, but according to the surgeon, some post op deficit was expected given the tumor's location, and this weakness was not related to the use of brainlab navigation.Hospitalization was prolonged by approximately four days.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 dissection path by approximately 25 mm from the intended location, resulting in the resection of non-lesional (normal) brain tissue, can be attributed to a combination of the following (in no particular order): a pre-operative patient scan used for registration that did not completely fulfill brainlab's scan requirements and was therefore suboptimal for surface matching registration: the scan did not include the top and sides of the patient's head and the skin reconstruction was not smooth and free of artifacts/distortion.If registration points are acquired on the patient's skin in areas not included in the scan and/or areas of distortion, this can cause the registration to not find an as accurate match as desired for navigation.A suboptimal distribution of points acquired on the skin for patient registration to navigation by the user, with points not acquired as necessary: points were not evenly distributed across both sides of the patient's head/face, points were not taken down either side of the patient's nose, and points were collected at or near areas that were not included in the scan.This can cause the brainlab cranial navigation software to not find an as accurate match as desired between the pre-operative image dataset and the actual patient anatomy.A movement of the patient's head within the non-brainlab head holder and/or movement of the patient reference array during the procedure (after registration was performed) due to insufficient rigid fixation and/or inadvertent forces applied at or after draping during the surgery.Relative movements between the reference array and the patient's head after registration cannot be compensated by the navigation.Only a slight contributing factor: a shift of the patient's brain may have occurred in between the preoperative image data used with navigation and the changed anatomical situation during the surgery, e.G.Due to the craniotomy and/ or loss of cerebrospinal fluid.This shift of the patient's brain cannot be recognized or compensated by the navigation, which uses the preoperative image data for display of instrument positions relative to the patient's anatomy.Apparently, the resulting deviation of the navigation display was not detected by the user with the necessary continued user verification of navigation accuracy after registration, and throughout the surgery.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 Description

What is the issue? a cranial surgery for resection of a right parietal lobe tumor approximately 35mm deep, 1.75cm³ in volume, and 15mm in diameter, was performed with the aid of the display by the brainlab navigation software cranial 3.1.A preoperative mri scan was acquired 11 days prior to the surgery, to use with navigation.During the procedure the surgeon: positioned the patient in supine 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.Used the navigated brainlab pointer to plan and mark the skin incision entry point.Removed the unsterile navigation reference array and draped the patient.Attached a sterile reference array, and re-verified navigation accuracy with the sterile pointer.Detected an approximate 1cm deviation in the display of navigation when comparing the actual location of the brainlab pointer to the skin incision marking.Removed the drapes, and performed a new patient registration in the same manner as the initial registration.Verified the accuracy of this second registration and accepted the registration to proceed.Draped the patient again and re-verified navigation accuracy with the sterile pointer, and judged the accuracy acceptable to continue.Used the aid of navigation to determine the dissection path and tumor location for tissue resection.Sent resected tissue samples to pathology, but was uncertain whether all of the lesion had been removed, based on the volume of the tissue resected.Decided to complete the surgery and close the patient before pathology returned their results.Pathology found no lesion was present in the resected samples, which were identified as normal brain tissue.The surgeon determined via post-operative scan that the location of the resected tissue deviated from the intended location by approximately 25mm, with the dissection path being dorsal and caudal to the target tumor, resulting in unintentional tissue dissection in the post central gyrus.A second (repeat) surgery was scheduled and performed five days later using the same brainlab navigation equipment, during which the tumor was successfully resected as intended.According to the surgeon: the outcome of the revision surgery using the same brainlab navigation equipment was successful as intended.The patient experienced a slight increase in agnosia, and according to the surgeon the agnosia was due to the entry caudal and dorsal to the intended target.It is not known whether the patient's agnosia is reversible or permanent.The patient also experienced some left facial weakness following the revision surgery, but according to the surgeon, some post op deficit was expected given the tumor's location, and this weakness was not related to the use of brainlab navigation.There are no further remedial actions necessary, done, or planned for this patient.Hospitalization was prolonged by approximately four days.

• 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: 10254228
• MDR Text Key: 205332414
• Report Number: 8043933-2020-00033
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481132439
• UDI-Public: 04056481132439
• 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: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22216-02B
• Device Catalogue Number: 22216-02B
• Device Lot Number: SW V.3.1.4.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2020
• 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