MAUDE Adverse Event Report: BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 2.1); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number	22214-02D
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2019
Type of Reportable Event	Serious Injury
Additional 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, and a second surgery was required to successfully complete the procedure as intended, despite according to the surgeon: the final outcome after the revision surgery was successful as intended.There was no (direct or increased) risk to harm a critical brain structure (e.G.Blood vessels or important brain tissue), neither due to the craniotomy nor the invasive steps (paths, dissections, resections) done at this surgery.There was no harm or negative effect to the patient, neither due to the original surgery nor due to the revision surgery/repeat anesthesia (of ca.3 hours).There are no further remedial actions necessary, done or planned for this patient.Hospitalization was prolonged only for the revision surgery, by five days.According to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the root cause for the deviation from the intended target by approximately 8 mm as estimated by the user surgeon, can be attributed to a shift of the patient's brain anatomy during surgery, when compared to the pre-operative mri scan used with navigation, due to the application of retractors on the patient's brain as the dissection path was created.This 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's anatomy.A further and to a lesser extent contributing factor, that can have added to the deviation, is a less than ideal point acquisition by the user during patient registration to navigation, not following the brainlab recommendations as required.The registration points were acquired in a region where the preoperative image dataset showed deformation of the skin causing surface discrepancies to the anatomical situation during the surgery, and no registration points were acquired at the characteristic bony areas of the patient's face.These factors may have caused the brainlab cranial navigation software to not find an as accurate match as desired in the region of interest for this specific procedure, between the preoperative image dataset and the actual patient anatomy.Apparently the resulting deviation of the navigation display was not recognized by the user (prior to applying the instrument path), with the necessary accuracy verification of navigation 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.Brainlab intends to reiterate the relevant topics regarding the use of the device to this customer.
Event or Problem Description
A cranial surgery for removal of a small spherical tumor approximately 9 mm in diameter located in the cerebellum, posterior to the brainstem and left of the third ventricle, was performed with the aid of the display by the brainlab navigation software cranial 2.1.A preoperative mri scan was acquired on (b)(6) 2019, to use with navigation.During the procedure the surgeon: positioned the patient in prone position in a non-brainlab headholder.Performed the initial patient registration on the preoperative mri using the soft touch 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 the registration to proceed.Removed the unsterile navigation reference array and draped the patient.Attached a sterile reference array, and re-verified navigation accuracy with the sterile pointer.Removed an existing bone flap from a previous surgery and opened the dura.Resected the tumor using the aid of navigation to confirm the location as the dissection path was created.Completed the surgery, and sent tissue samples for analysis by pathology.Results of the tissue analysis showed no tumor cells and only diseased cerebellar tissue.A post-operative mri showed the tumor had not been resected as planned; there was an approximately 8 mm deviation between the location of the resected tissue and the intended location of the tumor.A revision surgery took place on (b)(6) 2019 using the same brainlab navigation equipment and procedure, during which the tumor was successfully resected as intended; the revision surgery outcome was successful.According to the surgeon: the final outcome after the revision surgery was successful as intended.There was no (direct or increased) risk to harm a critical brain structure (e.G.Blood vessels or important brain tissue), neither due to the craniotomy nor the invasive steps (paths, dissections, resections) done at this surgery.There was no harm or negative effect to the patient, neither due to the original surgery nor due to the revision surgery/repeat anesthesia (of ca.3 hours).There are no further remedial actions necessary, done or planned for this patient.Hospitalization was prolonged only for the revision surgery, by five days.

• Brand Name: CRANIAL NAVIGATION SOFTWARE (VERSION 2.1)
• Common Device Name: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 9076090
• Report Number: 8043933-2019-00045
• Device Sequence Number: 2475498
• Product Code: HAW
• UDI-Device Identifier: 04056481000493
• UDI-Public: 04056481000493
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K092467
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2019

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: 22214-02D
• Device Catalogue Number: 71208
• Device Lot Number: SW V. 2.1.2
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other