MAUDE Adverse Event Report: BRAINLAB AG CRANIAL NAVIGATION SYSTEM (VERSION 4.0); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number 26615-01B

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/07/2021

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since instrument paths and tissue resections were applied in a different location in the brain than anticipated, with the brainlab device involved, despite according to the surgeon: the outcome of the surgery was successful as intended; the surgeon successfully resected the tumor using the aid of ultrasound and without navigation.There was no actual harm or negative effect to the patient due to the reported problem and/or unintended surgical steps performed with the aid of navigation, neither due to the prolongation of anesthesia by approximately 1 hour.However, there was an increased risk for harm due to resecting at the eloquent area of the brain, and any deviation of surgical trajectory could potentially cause more neurologic deficit.There were no further medical/surgical remedial actions necessary, done or planned for this patient.Hospitalization was not 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 of the inaccurate location of the resection by 10mm done with the aid of navigation was a suboptimal patient scan used to register the patient to navigation in combination with insufficient distribution of points acquired by the user for this registration, both not following brainlab requirements.Specifically, there were visible areas of skin shift (unnatural compression) on the scan possibly due to headphones or a mask, and registration points were collected by the user in these visible areas of skin shift and none were taken in the area of interest.This caused the cranial navigation software to not find an as accurate match in the region of interest as desired for this specific procedure in between the preoperative image dataset and the actual patient anatomy.Another contributing factor is the reuse of reflective marker spheres on the brainlab device that was used to perform the patient registration at this procedure.Reflective marker spheres are single use only; any damage to the reflective marker spheres can potentially affect proper visibility and recognition of the marker spheres by the camera and contribute to potential navigation inaccuracies.As a further contributing factor, the reference array was positioned approximately 37 cm away from the patient, which exceeded the recommended distance by brainlab, and the software displayed a warning to the user to position the reference closer to the region of interest, which the user chose to ignore to proceed.A large distance between the patient and the reference array can further contribute to inaccuracy during the procedure.Apparently the resulting deviation of the navigation display was not recognized by the user with the required thorough verification of the registration accuracy, and the necessary continued verification of navigation after draping, and throughout the procedure (prior to tissue resection).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 reiterate the relevant topics regarding the use of the device to this customer.

Event Description

A cranial surgery for resection of a right-sided tumor approximately 2.20cm³ in volume and 26mm from the skin surface, was performed with the aid of the display by the brainlab software cranial navigation 4.0.A pre-operative mri was acquired nine days prior to the surgery for use with navigation.During the procedure the surgeon: positioned the patient supine, attached the non-brainlab headholder to the patient, and attached the unsterile reference array to the headholder.Performed the initial patient registration on the pre-operative mri acquiring registration points on the patient's skin to match the display of the navigation to the current patient anatomy.Verified the accuracy of the registration and accepted it to proceed.The software displayed a warning to the user that the distance between the reference array and the patient was too large but the surgeon opted to cancel the warning message to proceed.Draped the patient and exchanged the unsterile reference array with the sterile reference array.Made the skin incision, created the bone flap, and opened the dura at the planned location.Used the navigated pointer to aid in locating the tumor, and resected tissue at the location indicated by navigation.Two tissue samples were sent to pathology, which reported that no cancerous tissue was found in the samples.Used an intraoperative (non-brainlab) ultrasound and determined the tumor was 10 mm away from the location indicated by navigation.Proceeded to resect the tumor successfully using the aid of ultrasound without the use of navigation.Completed the surgery.According to the surgeon: the outcome of the surgery was successful as intended; the surgeon successfully resected the tumor using the aid of ultrasound and without navigation.There was no actual harm or negative effect to the patient due to the reported problem and/or unintended surgical steps performed with the aid of navigation, neither due to the prolongation of anesthesia by approximately 1 hour.However, there was an increased risk for harm due to resecting at the eloquent area of the brain, and any deviation of surgical trajectory could potentially cause more neurologic deficit.There were no further medical/surgical remedial actions necessary, done or planned for this patient.Hospitalization was not prolonged either.

• Brand Name: CRANIAL NAVIGATION SYSTEM (VERSION 4.0)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer Contact: maura boyle ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 12591414
• MDR Text Key: 278760654
• Report Number: 8043933-2021-00066
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481141356
• UDI-Public: 04056481141356
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192703
• 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: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 26615-01B
• Device Catalogue Number: 26615-01B
• Device Lot Number: SW V. 4.0.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2021
• 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