MAUDE Adverse Event Report: BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 2.1.2); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number 22214C

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Human Factors Issue (2948); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2018

Event Type  malfunction  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since a biopsy was applied in a different location in the brain than anticipated with the brainlab device involved, despite according to the surgeon: the surgery was to retrieve a diagnostic sample, not to remove or treat the lesion.There were no negative effects to the patient, neither due to the biopsies nor due to prolong of surgery/anesthesia time (of ca.90 min.) 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.The same surgery was completed successfully as intended; with the desired (diagnostic/pathological) sample retrieved.There are no remedial actions necessary, done or planned for this patient.Hospitalization did not need to be 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 for the biopsies taken in a location different than anticipated with navigation involved, is a suboptimal patient registration for navigation (registration points were not sufficiently collected in all necessary regions and in the region of interest) at the initial registration for this specific case: the accuracy initially achieved did not fully meet the expectations of the user and a deviation of ca.3 mm apparently exceeded the clinically desired limits for this intended target point.Apparently the resulting deviation between displayed navigation information and the actual patient anatomy was not detected before the first biopsy attempt 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 re-iterate the relevant topics regarding the use of the device to this customer.

Event Description

A cranial surgery for a biopsy (for retrieval of a diagnostic sample) of a lesion with a size of ca.1 ccm, located ca.65 mm deep in the brain, has been performed with the aid of the brainlab navigation version 2.1.2.A pre-operative mri scan was acquired 3 days before the surgery, to use with navigation.A trajectory was planned for the procedure.During the procedure the surgeon: positioned the patient in a supine orientation.Performed the initial patient registration on the pre-op mri with surface matching to match the display of the navigation to the current patient anatomy.Verified the accuracy of the registration and determined the result as good.Removed the unsterile navigation reference array, sent the array to immediate use steam sterilization, and draped the patient.Attached the newly sterilized reference array, re-verified position of the entry point using the navigated pointer, and created a burr hole.Aligned the navigated instrument guide to the planned trajectory with entry point.Performed the biopsy with a navigated biopsy needle aligning to the planned trajectory.One (1) biopsy pass with 4 samples was performed as originally intended.Pathology informed that these samples are non-diagnostic (normal tissue).Checked the current navigation accuracy with the pointer, and determined that the navigation position display deviated near the location of the burr hole site.Undraped the patient and performed a new patient registration for navigation with surface matching, and re-confirmed the accuracy achieved.Opened the burr hole more to be able to access the correct entry point originally planned, and performed another biopsy pass with a navigated biopsy needle aligning to the same planned trajectory and target as before.One (1) pass with 3 samples was performed this time.These samples were diagnostic as desired.Closed the patient and concluded the surgery.The post-op ct scan indicated that the samples of the initial unsuccessful pass were taken ca.3 mm away from the planned target and trajectory.The 2nd successful biopsy pass was at the intended target location.According to the surgeon: the surgery was to retrieve a diagnostic sample, not to remove or treat the lesion.There were no negative effects to the patient, neither due to the biopsies nor due to prolong of surgery/anesthesia time (of ca.90 min.) 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.The same surgery was completed successfully as intended; with the desired (diagnostic/pathological) sample retrieved.There are no remedial actions necessary, done or planned for this patient.Hospitalization did not need to be prolonged either.

• Brand Name: CRANIAL NAVIGATION SOFTWARE (VERSION 2.1.2)
• Type of Device: IMAGE 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: markus hofmann ; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• MDR Report Key: 7398585
• MDR Text Key: 104852785
• Report Number: 8043933-2018-00010
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481000493
• UDI-Public: 04056481000493
• 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: 03/14/2018

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
• Device Operator: Physician
• Device Model Number: 22214C
• Device Catalogue Number: 71208
• Device Lot Number: SW V. 2.1.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2018
• Initial Date FDA Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2015
• 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): Other