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

Model Number 22216-02B

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

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

Event Date 06/25/2021

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since instrument paths and biopsies 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 samples collected from the lesion were diagnostic.There was no actual harm/negative clinical effect to the patient due to the reported problem/apparent navigation inaccuracy and/or unintended surgical steps performed with the aid of navigation.There was no report of prolonged anesthesia.There was no direct (or increased) risk of harm to a critical structure (e.G.Brain tissue/structure, blood vessels, etc.) due to the reported problem.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 deviating biopsy trajectory by approximately 4mm using navigation was a combination of the following factors: an inadequate patient scan used for registration in combination with a less than ideal distribution of points acquired by the user for patient anatomy registration to navigation, both not following brainlab's recommendations.Specifically, the points were not equally distributed on both sides of the patient's face with several points acquired on areas where significant distortion/artifacts were present in the scan e.G.Around the eyes and nose.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.A shift of the patient's brain anatomy during surgery (as seen on the post-operative mri scan), when compared to the pre-operative mri scan used with navigation, due to e.G.The burr hole and/or loss of cerebrospinal fluid.The shift of the patient's brain cannot be recognized or compensated by the navigation system, which uses the pre-operative image data for display of instrument positions relative to the patient anatomy.Both 4-sphere reference arrays (unsterile and sterile) used at this specific surgery were found to have bent marker posts when hardware was inspected by brainlab support approximately four months after the surgery.It is not known when the damage to the instruments occurred, so the potential use of damaged instruments for this surgery cannot be excluded as a possible factor.The instrument damage on both arrays likely occurred through improper handling at the user site, which apparently was not detected by the user after the damage occurred.The navigation software relies on the recognition of an exact same position and geometry of the navigation reference array in relation to the patient anatomy as it was during registration to navigation based on the pre-operative scan to the current patient anatomy, throughout the complete use of navigation during a surgery, in order to accurately track navigated instruments.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 accuracy after draping, and throughout the procedure (prior to making the incision).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 a diagnostic biopsy of an approximately 2x2cm lesion in the left parietooccipital region of the brain, was performed with the aid of the display by the brainlab navigation software cranial 3.1.A pre-operative mri was acquired one week prior to the surgery for use with navigation.During the procedure the surgeon: planned a trajectory pre-operatively on the mri in the brainlab software for the biopsy (entry and target point).Positioned the patient in a sitting position on the or table, placed the patient in a non-brainlab headholder, and attached the reference array to the headholder.Performed the initial patient registration on the pre-op mri acquiring registration points on the patient's skin to match the display of the navigation to the current patient anatomy, and verified the accuracy of the registration, but did not accept this registration and performed another registration in the same manner as the first.Verified the accuracy of the second registration and accepted it to proceed.Used the navigated pointer to mark the entry point on the patient's skin, draped the patient, and exchanged the unsterile reference array with the sterile reference array.Made the skin incision, used the navigated pointer to determine the burr hole location according to the pre-planned trajectory, and created the burr hole.Aligned the varioguide using navigation to the pre-planned trajectory, and passed the biopsy needle through the varioguide to the target location.Collected five biopsy samples as planned, and sent them to the pathology department which confirmed the samples were diagnostic.Completed the surgery.The day after the surgery, a post-operative mri was performed which showed that the actual trajectory of the biopsy needle deviated from the planned trajectory by approximately 4mm inferior to the planned entry point and 4mm anterior to the planned target point.According to the surgeon: the outcome of the surgery was successful as intended; the samples collected from the lesion were diagnostic.There was no actual harm/negative clinical effect to the patient due to the reported problem/apparent navigation inaccuracy and/or unintended surgical steps performed with the aid of navigation.There was no report of prolonged anesthesia.There was no direct (or increased) risk of harm to a critical structure (e.G.Brain tissue/structure, blood vessels, etc.) due to the reported problem.There were no further medical/surgical remedial actions necessary, done or planned for this patient.Hospitalization was not prolonged either.

• 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; 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: 12805367
• MDR Text Key: 284200432
• Report Number: 8043933-2021-00073
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481132439
• UDI-Public: 04056481132439
• Combination Product (y/n): N
• Reporter Country Code: RO
• 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
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22216-02B
• Device Catalogue Number: 22216-02B
• Device Lot Number: SW V. 3.1.4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2019
• 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): Other