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

Model Number 22216A

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

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

Event Date 09/01/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since biopsies were applied in a different location in the brain than intended with the brainlab device involved, despite according to the surgeon: - the surgery was to retrieve diagnostic sample (not to remove/treat tumor).- the risk for the patient for the to-be-performed biopsies was considered to be relatively low due to the location of the tumor at the surface and in non-eloquent cortex of the brain.- the surgery was completed successfully as intended with viable biopsy samples retrieved.- there were no negative effects to the patient, neither due to biopsies nor prolong of surgery/anesthesia (of ca.1h).- there are no further remedial actions necessary, done or planned for this patient due to this issue.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 intended with navigation involved, is that the navigation aid was used despite the accuracy of the virtual display of the navigation compared to the actual anatomy was less than desired and despite this was detected by the user with the necessary verification of registration accuracy before using the navigation information for surgery steps.The contributing factors for the insufficient accuracy of the virtual navigation display achieved by the user with the patient registration are: - the pre-operative mri scan was not performed according to the brainlab scan protocol, and contained (motion) artefacts, as well as significant skin shift (with also the donut markers appearing elliptically distorted).- the registration points acquired by the user during surface matching to register the anatomy to the mri were not adequately and sufficiently distributed as required by the navigation software.As a further contributing factor, a shift of the patient's brain might have occurred in between the pre-operative mri and the anatomical situation during the surgery, e.G.Due to the burr hole and loss of cerebrospinal fluid, potentially causing a difference in the location of the brain anatomy.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.Corresponding to the root cause, 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 located at the surface in the right parietal lobe of the brain, with a size of ca 15x20x20 mm, has been performed with the aid of the virtual display of the brainlab navigation.A pre-operative mri scan with donut markers attached was acquired the same day before the surgery, to use with navigation.This pre-op mri scan contained motion artefacts as well as significant skin shift (with also the donut markers appearing elliptically distorted).During the procedure the surgeon: - positioned the patient in a lateral orientation.- performed several attempts of the initial patient registration on the pre-op mri to match the virtual display of the navigation to the current patient anatomy, using different techniques with marker registration and with surface matching registration.- could not achieve a satisfactory match as determined with the necessary accuracy verification of the registration by the user.- decided to accept the best one of the registration match results achieved with the attempts, with a deviation of more than 5 mm to the actual patient anatomy determined with the verification, and to continue with the use of navigation for the surgery: the surgeon considered the risk for the patient for the to-be-performed biopsies to be relatively low due to the location of the tumor at the surface and in non-eloquent cortex of the brain.- draped the patient, and used the navigated pointer to pre-determine the location of the tumor and correspondingly of the needed burr hole, with at the same time attempting to manually compensate for the deviation in the display by shifting the entry point to use by ca.5mm in the opposite direction.- created the burr hole, and took 2 biopsy samples with a non-navigated surface needle.Theses samples were non-pathological, i.E.Not from the tumor.- expanded the exposure of the brain for visual access to see where the abnormal tissue was.The deviation of the location of the initially taken biopsies to the intended target, determined by visual inspection, was at least 5-10 mm.- visually adjusted the location of further biopsy samples taken.According to the surgeon: - the surgery was completed successfully as intended with viable biopsy samples retrieved.- there were no negative effects to the patient, neither due to biopsies nor prolong of surgery/anesthesia (of ca.1h).- there are no further remedial actions necessary, done or planned for this patient due to this issue.

• Brand Name: CRANIAL NAVIGATION SOFTWARE (VERSION 3.1)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB AG; kapellenstrasse 12; feldkirchen, 85622 ; GM 85622
• Manufacturer (Section G): BRAINLAB AG; kapellenstrasse 12; feldkirchen, 85622 ; GM 85622
• Manufacturer Contact: markus hofmann ; kapellenstrasse 12; feldkirchen, 85622 ; GM 85622 ; 89 9915680
• MDR Report Key: 6046314
• MDR Text Key: 58040060
• Report Number: 8043933-2016-00038
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481000479
• UDI-Public: 04056481000479
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K092467
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 22216A
• Device Catalogue Number: 22216A
• Device Lot Number: SW V. 3.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2016
• 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