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

Model Number 22216-02C

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190); Device Handling Problem (3265)

Patient Problems Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891)

Event Date 09/19/2022

Event Type  Injury  

Event Description

A cranial surgery for a craniotomy for removal of a tumor in the left frontal lobe with a superficial aspect that was adjacent/attached to the dura has been performed with the aid of the brainlab navigation software cranial 3.1.A pre-operative mri scan and ct scan were acquired before the surgery, to use with and register to the navigation.The two scans were aligned ("fused") within the brainlab software prior to the surgery.During the procedure the surgeon: positioned the patient supine in a non-brainlab headholder and attached the unsterile brainlab reference array.Performed the initial patient registration on the pre-operative patient scan acquiring registration points on the patient's skin to match the display of the navigation to the current patient anatomy verified the accuracy and deemed it not acceptable, and acquired additional registration points.Verified and accepted the accuracy of the registration to proceed.Marked the initial skin incision and the midline using the aid of the navigated pointer.Removed the unsterile reference array, draped the patient, and attached the sterile reference array.Verified the accuracy of the navigation by holding the sterile pointer to anatomical landmarks and deemed it still acceptable.Performed the skin incision where it was previously marked, and determined the location of the craniotomy using the aid of navigation.The craniotomy was performed (bone flap was removed), and the dura was opened where the craniotomy had been performed.Upon opening the dura, the sagittal sinus was unintentionally entered and began bleeding.The surgeon repaired the sinus using gel foam and paddy.The surgeon also noted that brain tissue was unintentionally resected/dissected from the superior sagittal sinus and a minor amount of brain tissue was taken from the unintended dissection path.An intraoperative ultrasound was introduced and the surgeon determined that there was a deviation in the display of the navigated instruments in the brainlab software compared to the actual position of the instruments as determined with the ultrasound imaging, and the craniotomy (and opening of dura) had not been performed as intended: a medio-lateral inaccuracy of approximately 20mm (navigation showed the pointer was 20mm more lateral than indicated by ultrasound/anatomical landmarks), and an anterior-posterior inaccuracy of approximately 15mm.The surgeon completed the surgery successfully with the assistance of ultrasound imaging.According to the surgeon: the sagittal sinus was unintentionally entered upon opening the dura and started bleeding; it was repaired during the surgery with gel foam and paddy.There was no permanent harm to the patient, nor were there any further (besides repair of the sagittal sinus) medical or surgical remedial actions necessary, done, or planned for this patient.Hospitalization was not prolonged either.The outcome of the surgery was successful by using the aid of ultrasound imaging.

Manufacturer Narrative

A risk to the patients' health could not be excluded for these specific circumstances, since a craniotomy was performed in another location than intended with the brainlab device involved, and there was a surgical intervention required to preclude a permanent impairment or damage (serious injury) - the sagittal sinus was unintentionally entered and required a repair, although: there was no permanent harm to the patient reported by the surgical registrar nor any further remedial actions (besides repair of the sagittal sinus) that would have been necessary currently there is no indication of a systematic error or malfunction of the brainlab device, nor of insufficient measures to minimize this anticipated risk as low as reasonably practicable a comprehensive investigation by brainlab regarding this specific event is currently ongoing and final conclusions are pending.Brainlab plans to issue a follow-up report to the fda upon completion of investigation.

Manufacturer Narrative

B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since a craniotomy was performed and the dura was opened in a different location in the brain than anticipated, with the brainlab device involved, and the sagittal sinus was unintendedly entered and started bleeding upon opening the dura, which was repaired during the surgery to preclude permanent impairment or damage, although according to the surgeon: the outcome of the surgery otherwise was successful as intended; the surgery was completed using the aid of ultrasound imaging.There were no other negative clinical effects to the patient reported, neither due to the prolongation of anesthesia by 15-30 minutes.There were no further remedial actions necessary, done or planned for this patient.Hospitalization was not prolonged either.H6: 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 craniotomy by approximately 20mm, done with the aid of navigation was: an insufficient distribution of registration points acquired by the user, in combination with an inadequate patient scan used for registration, both not following brainlab requirements.The user acquired points on indistinctive rounded areas like the forehead and did not acquire points on bony landmarks as required.The scan showed indications of appliances placed on the patient's skin which caused visible skin shift in the scan, and the scan did not include the entire patient's nose as required.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.As a potential contributing factor, a movement of the patient reference array due to a non-rigid fixation and/or inadvertent forces applied after patient registration was performed, resulting from the use of a damaged vario reference arm holding the reference array cannot be completely ruled out.The instrument damage likely occurred through improper handling at the user site, which apparently was not detected by the user after the damage occurred.A movement of the patient's head relative to the reference array or vice versa cannot be compensated by the navigation system and can result in a deviation between the registered patient image and the actual patient.Apparently, the resulting deviation in the navigation display was not recognized with the necessary continued user verification of navigation accuracy after registration, after draping, and throughout the procedure.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.H7: brainlab intends to reiterate the relevant topics regarding the use of the device to this customer.

• Brand Name: NAVIGATION SOFTWARE CRANIAL 3.1
• 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 pascarella ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 15783001
• MDR Text Key: 303570232
• Report Number: 8043933-2022-00062
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 04056481132439
• UDI-Public: 04056481132439
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K192703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22216-02C
• Device Catalogue Number: 71213A
• Device Lot Number: SW V. 3.1.5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2019
• 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): Required Intervention