MAUDE Adverse Event Report: BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 3.0); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number 22216

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

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

Event Date 07/28/2017

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, and the desired diagnostic sample was not retrieved, despite according to the surgeon: the surgery was to retrieve a diagnostic sample, not to remove or treat the lesion.The burr hole was in the intended location, and there were no further unplanned biopsy paths applied at this surgery.There was no (direct or increased) risk to harm a critical brain structure (e.G.Blood vessels or important brain tissue) due to the applied biopsy or path.There were no negative effects to the patient, neither due to biopsies nor surgery/anesthesia time (of ca.45 min.) other than planned revision biopsy surgery, 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 that is that the patient's head in the head holder most likely moved during the surgery.As a further contributing factor, a shift of the patient's brain might have occurred in between the pre-op mri and the anatomical situation during the surgery, e.G.Due to the bone flap and/ or loss of cerebrospinal fluid.Apparently the resulting deviation between displayed navigation information and the actual patient anatomy was not detected with the necessary accuracy verification to be performed 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.21mm, located deep in the brain, has been performed with the aid of the brainlab navigation version 3.0.A pre-operative mri scan was acquired the same day of the surgery, to use with navigation.A trajectory was planned for the procedure.During the procedure the surgeon: positioned the patient in a lateral 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 and draped the patient.Attached a sterile reference array, re-verified accuracy and aligned the navigated instrument guide to the planned trajectory with entry point.Rotated the instrument guide away from the surgery area, and created a burr hole corresponding to the entry point.Performed the biopsy with a navigated biopsy needle aligning to the planned trajectory with initial sample taken along the anticipated superior border of lesion.Pathology informed that this sample is non-diagnostic.Navigated the needle further (deeper) and took additional samples.Closed the patient and concluded the surgery.A post-op ct indicated that the samples were taken ca.5mm away from the planned trajectory.The desired diagnostic sample from the lesion was not retrieved , and a revision biopsy surgery is planned for this patient.According to the surgeon: the surgery was to retrieve a diagnostic sample, not to remove or treat the lesion.The burr hole was in the intended location, and there were no further unplanned biopsy paths applied at this surgery.There was no (direct or increased) risk to harm a critical brain structure (e.G.Blood vessels or important brain tissue) due to the applied biopsy or path.There were no negative effects to the patient, neither due to biopsies nor surgery/anesthesia time (of ca.45 min.) other than planned revision biopsy surgery, 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 3.0)
• 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: 6854421
• MDR Text Key: 85752786
• Report Number: 8043933-2017-00027
• Device Sequence Number: 1
• Product Code: HAW
• 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: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 22216
• Device Catalogue Number: 22216
• Device Lot Number: SW V. 3.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2015
• 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