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); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2018

Event Type  Injury  

Manufacturer Narrative

Fda informed brainlab inc (letter is dated (b)(6) 2018) that a report (report number mw5077893) was received through fda's medwatch program also from the initial reporter.A risk to the patient's health could not be excluded for these specific circumstances, since brain tissue has been resected in another region of the brain than intended with the brainlab navigation device involved, although: there is no indication of a systematic error or malfunction of the brainlab device corresponding measures to minimize this anticipated risk as low as reasonably practicable are already in place according to the hospital, the (whole) surgery was completed successfully as intended, the tumor was resected as intended, there were no observed negative clinical effects for this patient due to this issue (also not due to the surgery delay of 1.5 hours), and no remedial actions were planned or done 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 main root cause for the observed deviation of the navigation display compared to the actual patient anatomy is a movement of the navigation reference array and/ or a movement of the patient's head in the head holder.Details: since initial patient registration was confirmed by two surgeons, who judged the accuracy of the accepted match to be very good, and registration accuracy was re-confirmed after draping, the potential deviation was likely introduced only after draping.However, since a display deviation of a few mm was alleged already during the initial incision and muscle dissection, the navigation reference array may have likely moved shortly after draping/ exchange from unsterile to sterile array, and/ or the patient's head in the head holder might have moved during this period.Further, since a medial extension of the dural opening was also required and initial tissue samples obtained were non diagnostic, a potentially existing small deviation might have increased by an additional movement of the reference array and/ or patient head in the head holder during surgery, due to a not sufficient rigid fixation.Further contributing factors: a shift of the patient's brain might also have occurred in between the preoperative image data and the anatomical situation during the surgery, e.G.Due to the craniotomy and/ or loss of cerebrospinal fluid.A less than ideal point acquisition by the user during the patient registration, not completely following the brainlab recommendations as required (which can be attributed to the fact that the patient was positioned prone and the frontal face anatomy not easily accessible for point acquisition, and no points were acquired in and around the region of interest), which may cause the brainlab cranial navigation software to not find a match between the display of the preoperative image dataset and the actual patient anatomy that was as accurate as required at the region of interest for this specific procedure.Apparently the (full extent of the) deviation has not been recognized by the user with the necessary continued verification of accuracy throughout the procedure.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.Brainlab intends to: inform this hospital about the investigation results corresponding to the root cause, brainlab intends to re-iterate the relevant topics regarding the use of the device to this customer.

Event Description

An open tumor resection was performed with the aid of the brainlab cranial navigation system version 3.1.0 (on (b)(6) 2018).The tumor dimensions were 30 x 25 x 27.5 mm, it was located about 25 mm from the surface, in the left cerebellum.A pre-operative mri scan was acquired 7 days before the surgery, for use with navigation.During the procedure the surgeon: positioned the patient in prone orientation and attached the 4 sphere standard cranial reference array for navigation performed the initial patient registration on the pre-operative mri scan (to match the display of the navigation to the current patient anatomy) verified accuracy of the registration and determined it to be very good; registration accuracy was further confirmed by an additional surgeon draped the patient, verified registration accuracy and again determined it to be very good performed incision and muscle dissection, and suspected a potential deviation of navigation display and actual patient anatomy of a few mm already at this step performed craniotomy (25 x 25 mm) and opened dura with aid of navigation performed a medial extension of the dural opening due to the potential deviation (craniotomy did not have to be extended) removed tissue sample five times with aid of navigation, which were determined non diagnostic by pathology, thereby realizing the full extent of deviation was 10 mm.Decided to continue conventionally (not relying on navigation display) resected the actual tumor (the initial five resection spots were a few mm apart from each other and from the actual tumor location).Ended the surgery with a delay of 1.5 hours (time needed for pathology to review the five samples obtained initially).According to the hospital, the (whole) surgery was completed successfully as intended, the tumor was resected as intended, there were no observed negative clinical effects for this patient due to this issue (also not due to the surgery delay of 1.5 hours), and no remedial actions were planned or done for this patient due to this issue.Note: the deviation of navigation display and actual patient anatomy that occurred in this case was initially reported to be 1-1.5 inch.However, during follow-up with the customer, the physician corrected this value and confirmed the extent of deviation was 10 mm.

• 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: 7661835
• MDR Text Key: 113160503
• Report Number: 8043933-2018-00019
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481000479
• UDI-Public: 04056481000479
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2018
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2016
• 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