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 Consequences Or Impact To Patient (2199)

Event Date 03/11/2019

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 biopsy path and resections were applied in a different location in the brain than intended, with the brainlab device involved, despite according to the surgeon: there was no negative clinical effect to this patient due to this issue, specifically there was no harm of a critical structure due to the inaccurate biopsy path; the overall outcome of the surgery was successful (a diagnostic sample was obtained); there was no prolongation of surgery / anesthesia time nor a prolongation of hospitalization due to this issue; there are no 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 deviation of the planned trajectory compared to the actual trajectory by approximately 4 cm is: the user likely forgot to attach the interconnector of the drapelink reference unit under the sterile reference array after draping.I.E.The interconnector was attached under the reference array during the registration, but was not attached after the draping (or vice versa).This would introduce exactly a parallel shift of 4 cm as observed in this case.A further potential contribution factor is a slightly bent post on the sterile drapelink reference array.Apparently the deviation has not been recognized (prior to performing the biopsy) by the user with the necessary continued verification of accuracy throughout the procedure.Apparently navigation accuracy had not been verified in the sterile environment.There is no indication of a systematic error or malfunction of the brainlab navigation device.Corresponding brainlab measures to minimize this anticipated risk as low as reasonably practicable are already in place.Remedial action initiated: 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 (diagnostic sample) of a right frontal tumor (below motor tracks) has been performed with the aid of brainlab navigation version 3.1.1 (on (b)(6) 2019).The tumor was located 70 mm deep from the planned frontal approach, and had a size of about 14.5 cubic cm.A pre-operative mri scan was acquired 3 days prior to the surgery, to use with navigation.During the procedure the surgeon: positioned the patient in a supine orientation and attached the brainlab 4-sphere drapelink reference array for navigation; performed the initial patient registration on the pre-operative mri scan (surface registration using softouch) to match the display of the navigation to the current patient anatomy; verified the accuracy of the registration (by checking facial features) and judged the registration accuracy to be good; created a trajectory using the pointer (with enabled offset); planned the entry point using the pointer and marked it on the patient skin; draped the patient; performed incision and created a burr hole of 20-30 mm at the position of the marked entry point (without aid of navigation); attached the sterile reference array to the drapelink interface; assembled and setup the varioguide and realized that it did not align to the burr hole / trajectory; adjusted the entry point of the previously planned trajectory using the pointer by creating a new entry point at the position of the already existing burr hole (target point stayed the same); aligned the varioguide to the newly created trajectory; collected four tissue samples (as originally intended), which were found to be pathological (high grade lymphoma); completed the surgery; obtained a post-operative ct scan and realized that the actual trajectory runs parallel to the planned trajectory (deviation of about 4 cm, superior and posterior); according to the hospital/surgeon: there was no negative clinical effect for this patient due to this issue, specifically there was no harm of a critical structure due to the inaccurate biopsy trajectory.The overall outcome of the surgery was successful (a diagnostic sample was obtained) there was no prolongation of surgery / anesthesia time nor prolongation of hospitalization due to this issue.There are no 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; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• Manufacturer Contact: andrea miller ; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• MDR Report Key: 8498404
• MDR Text Key: 141446156
• Report Number: 8043933-2019-00010
• 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: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22216A
• Device Catalogue Number: 71205
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other