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

Model Number 22216-02C

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

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

Event Date 05/20/2021

Event Type  Injury  

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/corrected for surgery to be effective as intended), with the brainlab device involved, despite according to the surgeon there was no negative clinical effect to the patient, nor did the hospital/surgeon report any medical/surgical remedial action that would have been necessary, done or planned for this patient due to this issue.Currently there is no indication of a systematic error or malfunction of the brainlab device, nor of insufficient measures to minimize this anticipated risk as low as reasonably practicable.A comprehensive investigation by brainlab regarding this specific event is currently ongoing and final conclusions are pending.Brainlab plans to issue a follow-up report to the fda upon completion of investigation.

Event Description

A cranial surgery for a resection of a cerebellar tumor has been performed with the aid of the brainlab navigation software cranial 4.0.During the surgery, the patient was positioned prone and the neurosurgery registrar performed the registration of navigation to the preoperative scan using fiducials.The registrar planned the craniotomy using the aid of the display of navigation, and removed the bone flap.According to the surgeon, the location of the craniotomy was not in the intended location.The surgeon alleged that an inaccuracy in the display of navigation caused or contributed to the incorrect location of the craniotomy.The surgeon proceeded with the surgery by slightly 'refashioning' the craniotomy, with the size of the correction/enlargement deemed to be minimal, according to the surgeon.The surgeon completed the surgery successfully, using conventional methods and without the use of navigation.According to the surgeon, there was no actual harm or negative clinical effect to the patient due to this issue, although the surgeon stated there was an increased risk of harm due to the proximity of the location of the craniotomy to the sinus.There has been no report of any (further) medical/surgical remedial action that would have been necessary, done or planned for the patient due to this issue.

Manufacturer Narrative

B2, h1: 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/re-fashioned 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 extension/re-fashioning of the craniotomy was considered as only trivial damage.- the outcome of the surgery was successful; the tumor was resected as intended.- there was no harm or negative effect to the patient, neither due to the surgery nor for the craniotomy extension/re-fashioning; anesthesia was not prolonged.- there are no further remedial actions necessary, done or planned for this patient.Hospitalization was not prolonged.H6: 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 reportedly inaccurate location of the craniotomy done with the aid of (allegedly inaccurate) navigation was most likely one or more of the following potential factors (in no particular order): - a potentially suboptimal patient registration with an accuracy that was less than desired for the procedure to be performed.There was possible movement or shift of the adhesive fiducial markers between the preoperative patient scan used for registration and the actual patient during patient registration at the procedure and minimal/no fiducial markers (for planning and acquiring landmark registration points) distributed at or surrounding the region of interest at the back of the patient's head.Both of these factors may have contributed to a registration match that was not as accurate as desired at the region of interest (e.G.Due to error propagation).- factors unrelated to brainlab navigation and/or brainlab devices, such as difficulties with drilling (independent from the use of navigation) that was reported by the surgical registrar who planned and performed the craniotomy.Due to the limited information of the reported inaccuracy and alleged navigation inaccuracy, including limited details surrounding the circumstances of how navigation was concluded as allegedly inaccurate, it cannot be definitively concluded that navigation was (or had become) inaccurate during the procedure.Therefore, it's possible non-navigation related factors, such as the reported drilling difficulties, may have been the root cause or a contributing factor to the allegedly incorrect location of the performed craniotomy.In the case that a potentially suboptimal registration was the root cause or a contributing factor to the alleged navigation inaccuracy and incorrect craniotomy, the resulting deviation of the navigation display between the registered patient scan and the actual patient was apparently not recognized by the user with the necessary and appropriate accuracy verification directly after registration (during verification step, before accepting it) and throughout the procedure during planning and performing of the craniotomy.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 reiterate the relevant topics regarding the use of the device to this customer.

Event Description

A surgery for resection of a tumor located at the cerebellum, approximately 15mm³ with a depth of roughly 31 mm from the skin surface, was performed with the aid of the display by the brainlab navigation software cranial 3.1.During the procedure the surgeon: - positioned the patient prone on the operating table in a non-brainlab headholder - acquired points on fiducial markers on the patient's skin to match pre-planned points in the navigation software, and verified and accepted the accuracy of this registration to proceed.- planned the skin incision with the aid of navigation and marked the entry point on the patient's skin.- prepped and draped the patient, exchanging the unsterile reference array for the sterile reference array.- performed the skin incision and planned the craniotomy on the bone using the aid of navigation.- performed the craniotomy.The second (consultant) surgeon entered the or at this time and stated that there was a deviation in the display of navigation compared to the position of the patient's anatomy and the sinus was slightly exposed.The initial surgeon (surgical registrar) noted there were difficulties with drilling during the craniotomy (not related to the navigation).The surgery continued without the use of navigation, the craniotomy was extended ('slightly refashioned' per the surgeon), and the surgery was completed successfully.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 extension/re-fashioning of the craniotomy was considered as only trivial damage.- the outcome of the surgery was successful; the tumor was resected as intended.- there was no harm or negative effect to the patient, neither due to the surgery nor for the craniotomy extension/re-fashioning; anesthesia was not prolonged.- there are no further remedial actions necessary, done or planned for this patient.Hospitalization was not prolonged.

• 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
• MDR Report Key: 12016353
• MDR Text Key: 256715389
• Report Number: 8043933-2021-00045
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481141356
• UDI-Public: 04056481141356
• Combination Product (y/n): N
• PMA/PMN Number: K192703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22216-02C
• Device Catalogue Number: 22216-02C
• Device Lot Number: SW V. 3.1.5
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other