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

Model Number	22216-01A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/26/2019
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 a craniotomy deviated from the desired location (and needed to be extended for surgery to be effective as intended), with the brainlab device involved, despite according to the surgeon: the deviation was detected after the craniotomy before any critical surgical steps were performed (such as resection of brain tissue).The outcome of the surgery was successful; the tumor was resected 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 done at this surgery.There was no harm or negative effect to the patient, neither due to the surgery or craniotomy extension nor due to prolonged anesthesia (of ca.90 min) there are no further remedial actions necessary, done or planned for this patient.There was no 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 for the deviation of the navigation display compared to the actual patient anatomy by approximately 10 - 20 mm was a combination of the following: a movement of the patient's head within the non-brainlab head holder during the surgery relative to the navigation reference array, due to an insufficiently rigid fixation.It was determined after the surgery and confirmed by the surgeon that the patient's head had slipped in the pins of the non-brainlab head holder (i.E.The pins of the head holder were not fully engaged in the patient's skull).A likely movement of the navigation reference array relative to the patient anatomy, due to inadvertent force applied to the reference during the surgery (e.G.A user resting their arms on the navigation reference array).Relative movements of the patient's head within the head holder and the reference array cannot be compensated by the brainlab cranial navigation system.Apparently the deviation has not been recognized (while performing the craniotomy) by the user with the necessary continued verification of accuracy 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 resection of a right posterior tumor was performed with the aid of the display by the brainlab navigation software cranial 3.1.A preoperative mri scan was acquired on (b)(6) 2019, to use with navigation.During the procedure the surgeon: positioned the patient in a supine position in a non-brainlab headholder.Re-positioned (re-pinned) the patient's head in the non-brainlab headholder multiple times.Performed the initial patient registration on the preoperative mri acquiring registration points on the patient's skin to match the display of the navigation to the current patient anatomy, verified accuracy of the registration and determined it not good enough for the procedure.Repeated patient registration on the same mri scan, verified the accuracy of the registration, judged it to be good, and accepted the registration to proceed.Planned the location of the craniotomy using the aid of navigation.Removed the unsterile navigation reference array and draped the patient.Attached a sterile reference array, and re-verified navigation accuracy with the sterile pointer, judging it to be good.Performed the craniotomy.Removed the bone flap, verified accuracy, and detected a deviation of approximately 10-20mm.Extended the craniotomy by approximately 2x4cm.Continued the surgery resecting the tumor using the aid of navigation despite the detected deviation (per the surgeon "using it with a grain of salt") completed the surgery.According to the surgeon: the deviation was detected after the craniotomy before any critical surgical steps were performed (such as resection of brain tissue).The outcome of the surgery was successful; the tumor was resected 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 done at this surgery.There was no harm or negative effect to the patient, neither due to the surgery or craniotomy extension nor due to prolonged anesthesia (of ca.90 min) there are no further remedial actions necessary, done or planned for this patient.There was no 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
• MDR Report Key: 9098397
• Report Number: 8043933-2019-00047
• Device Sequence Number: 2665128
• Product Code: HAW
• UDI-Device Identifier: 04056481000479
• UDI-Public: 04056481000479
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 08/26/2019

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: 22216-01A
• Device Catalogue Number: 71202A
• Device Lot Number: SW V. 3.1.4
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/20/2019
• 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: Other