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

Model Number 22216C

Device Problems Off-Label Use (1494); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Nerve Damage (1979)

Event Date 04/18/2019

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since a craniotomy and resections were applied in a different location in the brain than intended, with the brainlab device involved, and therewith led to harm of critical structures within the brain.According to the hospital, the visual cortex had been damaged while operating on the left side and resecting tissue at an unintended location.The patient is blind after the surgery.According to the results of this technical investigation and the information provided by the hospital, it can be concluded that the root cause of the mix-up of patient side (left side operated instead of right side) can be attributed to use of the images displayed by the brainlab navigation system for diagnostic purpose (which is not an intended use of the system), and a misunderstanding by the user in regard to a specific software feature (image orientation setting).Details: the user had expected a "radiological view" with the patient's left side displayed on the navigation screen's right-hand side (as is common setting in pacs viewers), but the cranial navigation displayed a "neurosurgical view" with patient's left side displayed on the navigation screen's left-hand side (as is commonly used by neurosurgeons during the surgical procedure).The patient orientation is defined in a setting in the cranial navigation software (image orientation dialog).The images displayed by the cranial navigation software during the surgery were labeled correctly (and according to the defined setting).The brainlab device did not provide any wrong or conflicting information.Apparently the mix-up of patient side has not been recognized by the user (prior to performing the craniotomy/resections) with the corresponding measures in place.The surgeons neither verified the patient orientation setting in the cranial navigation software nor the image labeling displayed by the cranial navigation software (and if that matched the actual patient orientation) before/during the surgery.(further, note that had the surgeons actually used brainlab navigation (e.G.Navigated pointer), they would have realized the mix-up since the navigation system would have shown them the instrument on the opposite side than expected and hence this would have actually prevented a mix-up of the patient side operated on.) 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.In accordance with (b)(4), the displayed images on the brainlab navigation systems are not suitable for diagnostic use.Brainlab intends to re-iterate the relevant topics regarding the use of the device to this customer.

Event Description

A cranial surgery for tumor resection has been performed with the aid of brainlab navigation version 3.1.4 (on (b)(6) 2019).The tumor was located in the right parietal lobe, close to the bone surface, and the tumor volume was 77, 5 cm³.During the procedure the surgeons: positioned the patient in a prone orientation.Loaded image data in the brainlab navigation system.Decided not to use (further) aid of navigation (due to prone patient positioning, tumor size and tumor location.Planned a craniotomy conventionally, based on the images displayed by the brainlab navigation system.Detected that they had operated the patient on the wrong side, when they did not find the tumor (operated on left side when right side was intended).Planned a second craniotomy conventionally and resected the tumor.According to the hospital: the left side of the patient was operated (when the right side was intended to be operated).A second craniotomy was done and the tumor was resected after the mix-up of the patient side had been detected (in the same surgery).The visual cortex had been damaged (while operating on the left / not intended side), and the patient is blind after the surgery.The surgery / anesthesia time was prolonged by 2-3 hours; hospitalization was not prolonged.Further: both surgeons had examined the dataset one day before the surgery, and the correct (right) side was explained to the patient in the patient clarification on that day (using the hospital's standard pacs viewer).Apparently mistakes had occurred in the time-out procedure before the actual surgery: the surgeons neither checked the diagnosis in the patient's files (also not which side to be operated) nor which procedure steps have been clarified before the surgery.One of the surgeons did not keep his office hours and should not have operated.

• 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: 8669601
• MDR Text Key: 147085593
• Report Number: 8043933-2019-00025
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481132439
• UDI-Public: 04056481132439
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22216C
• Device Catalogue Number: 22216C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2018
• 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): Disability