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

Model Number	22216-02D
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A cranial surgery for a biopsy of a lesion in the brain, located ca.30-40mm deep in the brain and with a size of ca.0.27ccm (ca.8mm diameter), has been performed with the aid of the brainlab navigation software cranial 3.1.One biopsy pass with 8 samples was intended.The surgeon did not retrieve the desired diagnostic sample at this surgery with 2 biopsy attempts in the same planned path, and determined from a post-op mri scan that the samples taken had missed the lesion, at the first attempt by ca.1cm too short, and at the second attempt by ca.5mm medial, from the desired anatomy target.According to the surgeon (treating clinician): the purpose of this surgery was to receive a diagnostic sample, not to remove or treat the lesion.The desired pathological/diagnostic sample was not retrieved at this surgery.A revision surgery to retrieve the diagnostic sample is intended to be scheduled.There was no reported direct (or increased) risk of harm to a critical structure due to the deviating location of the brain biopsies.There was no harm or negative effect to the patient reported, also not due to the surgery/anesthesia prolong of ca.30-60min.There were further no remedial actions reported necessary, done or planned for this patient.There was also no reported prolong of hospitalization.
Additional Manufacturer Narrative
B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since biopsies were performed in a different location in the brain than anticipated and planned with the brainlab navigation involved, despite according to the surgeon (treating clinician): the purpose of this surgery was to receive a diagnostic sample, not to remove or treat the lesion.The desired pathological/diagnostic sample was not retrieved at this surgery.A revision surgery to retrieve the diagnostic sample is intended to be scheduled.There was no reported direct (or increased) risk of harm to a critical structure due to the deviating location of the brain biopsies.There was no harm or negative effect to the patient reported, also not due to the surgery/anesthesia prolong of ca.30-60min.There were further no remedial actions reported necessary, done or planned for this patient.There was also no reported prolong of hospitalization.H6: the device evaluation is currently ongoing.Clinical clarifications necessary for the device evaluation could only be retrieved by brainlab on apr 16, 2025, after close and continued follow-up with the hospital.Brainlab intends to issue a follow-up report upon completion of the device evaluation.
Additional Manufacturer Narrative
A risk to the patient's health could not be excluded for these specific circumstances, since biopsies were performed in a different location in the brain than anticipated and planned with the brainlab navigation involved, despite according to the surgeon (treating clinician): - the purpose of this surgery was to receive a diagnostic sample, not to remove or treat the lesion.- the desired pathological/diagnostic sample was not retrieved at this surgery.A revision surgery to retrieve the diagnostic sample is intended to be scheduled.- there was no reported direct (or increased) risk of harm to a critical structure due to the deviating location of the brain biopsies.- there was no harm or negative effect to the patient reported, also not due to the surgery/anesthesia prolong of ca.30-60min.- there were further no remedial actions reported necessary, done or planned for this patient.There was also no reported prolong of hospitalization.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 biopsy location and path, it can be concluded that the root cause of the first biopsy attempt location in the brain, performed with the aid of navigation, deviating by ca.1cm too shallow from its intended target point, is:.- a shift of the navigation reference array on the non-brainlab head holder during the surgery due inadvertent forces applied by the user, for e.G.At exchange of the unsterile to the sterile array or hitting it at draping, after the patient scan registration to navigation.A relative shift in between the reference array and the patient's head fully explains the observed shift deviation, whereas there is no indication that a movement of the patient's head in the head holder would have occurred at this surgery.The fact that this deviation was no longer existent after a new patient anatomy registration to navigation with an intra-operative ct, establishing again the correct current relation between the patient's head and the reference array, further supports that the reference array must have moved before the first biopsy attempt.Movement of the reference array after patient registration to navigation disrupts the coordinate system established during the registration and causes a deviation between the displayed image scan, on which the navigated instruments are tracked, and the actual patient anatomy.This movement cannot be compensated by the navigation software.Apparently, the resulting deviation of the anatomy location displayed by the navigation was not recognized by the user with the required thorough verification of the navigation accuracy throughout the surgery, for e.G.After draping with array exchange, and before applying significant invasive surgical actions.Regarding the second biopsy attempt the surgeon decided to insert the biopsy needle 1cm deeper when the navigation displayed the planned/intended target point in the middle of the lesion reached - there is no contribution by the navigation display guidance, with the navigation accurate as desired, to this second attempt missing the lesion volume with the biopsy needle passed too deep, ca.5mm after the border of the lesion: navigation and imaging data provided for this surgery show that the needle was placed in the actual anatomy accurately as to the display by the navigation, including correct display of the depth actually applied.The shift existent for the first biopsy attempt was addressed by the new intra-operative ct scan with anatomy registration to navigation, with the navigation accuracy restored before the second biopsy attempt.Apparently due to the outcome experience of the first biopsy attempt, the surgeon decided to continue to insert the biopsy needle deeper than the planned target point determined with navigation.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 or Problem Description
A cranial surgery for a biopsy of a lesion in the brain, located ca.30-40mm deep in the brain and with a size of ca.0.27ccm (ca.8mm diameter), has been performed with the aid of the brainlab navigation software cranial 3.1.One biopsy pass with 8 samples was intended.The surgeon did not retrieve the desired diagnostic sample at this surgery with 2 biopsy attempts in the same planned path, and determined from a post-operative mri scan that the samples taken had missed the lesion, at the first attempt by ca.1cm too short from the planned target point, and at the second attempt too deep (medial) by ca 5mm from the lesion volume border.According to the surgeon (treating clinician): - the purpose of this surgery was to receive a diagnostic sample, not to remove or treat the lesion.- the desired pathological/diagnostic sample was not retrieved at this surgery.A revision surgery to retrieve the diagnostic sample is intended to be scheduled.- there was no reported direct (or increased) risk of harm to a critical structure due to the deviating location of the brain biopsies.- there was no harm or negative effect to the patient reported, also not due to the surgery/anesthesia prolong of ca.30-60min.- there were further no remedial actions reported necessary, done or planned for this patient.There was also no reported prolong of hospitalization.

• Brand Name: CRANIAL NAVIGATION SOFTWARE (VERSION 3.1)
• Common Device Name: 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: markus hofmann ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 21857580
• Report Number: 8043933-2025-00026
• Device Sequence Number: 18103357
• Product Code: HAW
• UDI-Device Identifier: 04056481132439
• UDI-Public: 04056481132439
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K192703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 22216-02D
• Device Catalogue Number: 26650B
• Device Lot Number: SW V. 3.1.6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Supplement Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown