MAUDE Adverse Event Report: BRAINLAB AG NAVIGATION SOFTWARE CRANIAL EM 1.1; IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC, PRODUCT CODE: HAW

Model Number 22240-06C

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

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 08/23/2023

Event Type  Injury  

Manufacturer Narrative

B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since instrument paths and tissue resections were performed at a different location in/near the brain than anticipated, with the brainlab device involved, and according to the surgeon: the planned procedure was completed as intended (successful nasal sinus lesions removal).However, a csf leak was detected by the surgeon at the end of the surgery after deviating instrumentation with aid of navigation, which required immediate surgical intervention (mucosal graft and packing) to avoid/revert permanent damage to the patient, and was repaired successfully at this same surgery.The surgery/anesthesia was prolonged by ca.1.5h for this surgical intervention; further, an additional scar beyond the csf leak is anticipated because of extensive packing, and the patient will need lumbar drain.It is unknown at this point of time if further potential (reversible/permanent) csf-leak-related complications will occur.Hospitalization will be prolonged by min.2 days or more for this patient (originally planned as an outpatient surgery).H6: according to the results of the brainlab technical investigation and the information provided by the hospital, it can be concluded that the root cause of ca.20 mm deviation of actual vs.Displayed instrument position when navigating the brainlab suction tube with straight tip end at the right anterior ethmoid roof with aid of navigation is: incorrect calibration of the brainlab suction tube with straight tip end resulting in a deviation of actual instrument position on patient anatomy versus instrument position displayed on the registered pre-operative patient image scan.Inaccurate calibration can occur due to calibration being performed outside or near the edge of the em field and/or position of the tool tip inside the calibration cone not being optimal.After occurrence of a csf leak, the surgeon verified accuracy of the tool calibration, and detected a deviation of approx.20 mm.The surgeon recalibrated the instrument and accuracy improved but there was still a deviation of about 15 mm.No further recalibration was performed by the surgeon since aid of navigation was no longer needed at completion of the procedure.Apparently, the resulting deviation between the actual instrument position during the surgery and the instrument position on the registered pre-operative patient image scan displayed by the navigation was not recognized by the user with the required thorough verification of the instrument calibration accuracy, nor with the necessary continued.Verification of navigation accuracy throughout the procedure.Reportedly continued.Verification of navigation accuracy was not performed 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 re-iterate the relevant topics regarding the use of the device to this customer.

Event Description

An endoscopic sinus surgery (ethmoidectomy), with a target region at a depth of 1-2 mm and a size of 4 mm, to treat chronic sinusitis and polypoid mass lesions, has been performed with the aid of the brainlab nav.Sw cranial em 1.1 (on (b)(6) 2023).Three pre-operative ct scans were acquired 78 days prior to the surgery (on (b)(6) 2023), to use with navigation.During the procedure the surgeon: positioned the patient supine, with a round support pillow (donut) under the head, and attached the non-invasive em patient reference for navigation to the patient's forehead with tape.Performed the patient registration with surface matching by acquiring registration points on the patient's skin surface with the em registration pointer to match the display of the navigation to the current patient anatomy, verified the accuracy of the patient registration and accepted the registration to proceed calibrated the brainlab suction tube with straight tip end and the brainlab suction tube with curved tip end using the sterile em pointer.Performed a septoplasty (surgical procedure to straighten a deviated septum) without aid of navigation.Performed bilateral sinus surgery using aid of navigation, beginning on the patient's left side, then moved to the right side (maxillary sinus, then anterior ethmoid) upon completing surgery on the right side, used the navigated brainlab suction tube with straight tip end, and observed a csf leak at the right anterior ethmoid roof.Verified the accuracy of the calibration of the brainlab suction tube with straight tip end and detected a deviation of about 20 mm.Verified the accuracy of the calibration of the sterile em pointer which was deemed acceptable recalibrated the brainlab suction tube with straight tip end and determined still a deviation of about 15 mm.Performed no further recalibration, since navigation was not needed at completion of the procedure.Completed the surgery: according to the hospital / surgeon: the planned procedure was completed as intended (successful nasal sinus lesions removal).However, a csf leak was detected by the surgeon at the end of the surgery after deviating instrumentation with aid of navigation, which required immediate surgical intervention (mucosal graft and packing) to avoid/revert permanent damage to the patient, and was repaired successfully at this same surgery.The surgery/anesthesia was prolonged by ca.1.5h for this surgical intervention; further, an additional scar beyond the csf leak is anticipated because of extensive packing, and the patient will need lumbar drain.It is unknown at this point of time if further potential (reversible/permanent) csf-leak-related complications will occur.Hospitalization will be prolonged by min.2 days or more for this patient (originally planned as an outpatient surgery).

• Brand Name: NAVIGATION SOFTWARE CRANIAL EM 1.1
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC, PRODUCT CODE: HAW
• 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; muenchen, 81829 ; GM 81829
• MDR Report Key: 17787149
• MDR Text Key: 323894189
• Report Number: 8043933-2023-00063
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22240-06C
• Device Catalogue Number: 22242A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2018
• 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): Hospitalization; Required Intervention