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); Insufficient Information (3190)

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

Event Date 09/02/2021

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since tissue resections were performed in a different location in the brain than anticipated, with the brainlab device involved, despite no negative clinical effect to the patient was reported by the hospital, nor any (further) medical/surgical remedial action that would have been necessary, done or planned for this patient due to this issue (besides revision biopsy).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 biopsy (to only retrieve a diagnostic sample and not to remove the lesion/treat the disease) has been performed with the aid of the brainlab navigation software cranial 3.1 (on (b)(6) 2021).A pre-operative mri scan was acquired (not following brainlab scan protocol) one day before the surgery (on (b)(6) 2021), to use with navigation.A trajectory was planned.During the procedure the surgeon: performed the image registration with surface matching by acquiring registration points on the patient's skin surface with the brainlab z-touch to match the display of the navigation to the current patient anatomy.Verified the accuracy of the registration using the brainlab pointer and accepted the registration to proceed.After draping, planned the entry point of the skin incision using aid of navigation.Obtained tissue samples using the brainlab varioguide and brainlab-distributed biopsy needle.After surgery, the actual biopsy path in the brain was found to deviate from the planned biopsy trajectory (in the target point), and the tissue samples taken were non-diagnostic/non-conclusive.According to the hospital: the outcome of the surgery was not successful as intended (biopsy result was non-diagnostic/non-conclusive).A revision biopsy procedure was performed on (b)(6) 2021 without aid of navigation and was completed successfully as intended.No negative clinical effect to the patient was reported by the hospital, nor any (further) medical/surgical remedial action that would have been necessary, done or planned for this patient due to this issue (besides revision biopsy).

Manufacturer Narrative

B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since instrument path and tissue resections were applied in a different location in the brain than anticipated, with the brainlab device involved, despite according to the surgeon: there was no negative clinical effect to the patient due to the instrument path/tissue resections at unintended location.A revision biopsy procedure was performed (on (b)(6) 2021) without aid of navigation and was completed successfully as intended.There were no (further) medical/surgical remedial action necessary, done or planned for this patient due to this issue (besides revision biopsy).H6: 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 reported deviation from the intended target is due to the combination of the following factors: the pre-surgical mri scan used that did not fulfill the brainlab requirements, i.E.Did not have a smooth, evenly displayed 3-d skin surface with low distortion, in combination with a point acquisition by the user for the patient registration to navigation not performed as required: points were not taken in all necessary areas including both sides of the patient's face, head, and the entire profile of the nose.As a result, this most likely caused the navigation software to not find an as accurate match as desired in the region of interest for this specific procedure, between the pre-operative image dataset and actual patient anatomy, as needed for accurate display of instrument locations.Movement of the patient's head in the non-brainlab head holder due to insufficient rigid fixation or inadvertent forces after draping during the surgery and before the incision was made and varioguide was used (to drill/make the burr hole/navigate biopsy needle).Relative movements between the reference array and the patient's head after registration cannot be compensated by the navigation.Apparently the resulting deviation of the navigation display was not detected by the user before making the incision, burr hole, and inserting the biopsy needle using the varioguide, with the necessary continued user verification of accuracy after draping and throughout the surgery not sufficiently performed.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 Description

A cranial surgery for a biopsy (to only retrieve a diagnostic sample) has been performed with the aid of the brainlab navigation software cranial 3.1.4 (on (b)(6) 2021).A pre-operative mri scan was acquired (not following brainlab scan protocol) one day before the surgery (on (b)(6) 2021), to use with navigation.A trajectory was planned.During the procedure the surgeon: positioned the patient in prone position on the or table (with patient's head turned towards the right).Performed the image registration with surface matching by acquiring registration points on the patient's skin surface with the brainlab z-touch to match the display of the navigation to the current patient anatomy.Verified the accuracy of the registration using the brainlab pointer and accepted the registration to proceed.After draping, planned the entry point of the skin incision using aid of navigation.Obtained tissue samples using the brainlab varioguide and brainlab-distributed biopsy needle.In a post-operative scan the surgeon determined that the actual biopsy path in the brain deviated from the planned biopsy trajectory, and the tissue samples taken were found to be non-diagnostic/non-conclusive.According to the hospital: the outcome of the surgery was not successful as intended (biopsy result was non-diagnostic/non-conclusive).There was no negative clinical effect to the patient due to the instrument path/tissue resections at unintended location.A revision biopsy procedure was performed (on (b)(6) 2021) without aid of navigation and was completed successfully as intended.There were no (further) medical/surgical remedial action necessary, done or planned for this patient due to this issue (besides revision biopsy).

• 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: 12545588
• MDR Text Key: 273748220
• Report Number: 8043933-2021-00061
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481132439
• UDI-Public: 04056481132439
• 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: 09/02/2021

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
• Device Operator: Health Professional
• Device Model Number: 22216-02B
• Device Catalogue Number: 22216-02B
• Device Lot Number: SW V. 3.1
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 09/29/2021
• Supplement Dates Manufacturer Received: 09/02/2021
• Supplement Dates FDA Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other