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

Model Number 22214-02D

Device Problems Use of Device Problem (1670); Defective Device (2588); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 10/21/2019

Event Type  Injury  

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, despite according to the hospital: there are no negative clinical effects for this patient due to this issue, and there is no revision surgery planned.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 craniotomy for a tumor resection was performed on (b)(6) 2019 with the aid of brainlab navigation system cranial 2.1.During the procedure the surgeon: positioned the patient in a non-brainlab headholder and attached the unsterile navigation reference array.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.Verified the accuracy of registration and, after multiple registration attempts, determined the registration accuracy as acceptable for the procedure, although not perfect.Removed the unsterile reference array, draped the patient, attached the sterile reference array, and verified accuracy again and noted the same level of acceptable accuracy.Resected the tumor, sent tissue samples to pathology for analysis, and completed the surgery.Pathology results did not show any tumor tissue in the samples.Post-operative scans performed the next day showed that the tumor was not resected.According to the hospital, the patient did not suffer any negative clinical effects due to the surgery, and no revision surgery is planned.

Event Description

A craniotomy for a resection of a right frontal lobe tumor approximately 5mm in diameter was performed on october 21, 2019 with the aid of brainlab navigation system cranial 2.1.A pre-operative mri scan was acquired on oct 17, 2019 to use with navigation.During the procedure the surgeon: positioned the patient in a non-brainlab headholder and attached the unsterile navigation reference array.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 the accuracy of registration and, after multiple registration attempts, determined the registration accuracy as acceptable for the procedure, although not perfect.Removed the unsterile reference array, draped the patient, attached the sterile reference array, and verified accuracy again and noted the same level of acceptable accuracy.Resected the tumor, sent tissue samples to pathology for analysis, and completed the surgery.Pathology results did not show any tumor tissue in the samples.Post-operative scans performed the next day showed that the surgery was not successful: the tumor was not resected as intended, with a reported deviation of 1.5cm of the resection cavity from the intended location.According to the hospital: there was no harm or negative clinical effect due to this issue, and there was no prolongation of anesthesia.The patient is planned to receive radiation therapy for treatment of the tumor.There are no other remedial actions necessary, done or planned for this patient.There was no prolonged hospitalization either.

Manufacturer Narrative

B2, h1: 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 the tumor was not resected as intended, despite according to the hospital: there was no harm or negative clinical effect due to this issue, and there was no prolongation of anesthesia.The patient is planned to receive radiation therapy for treatment of the tumor.There are no other remedial actions necessary, done or planned for this patient.There was no prolonged hospitalization either.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 1.5cm deviation from intended target is a less than ideal point acquisition by the user for patient registration, in combination with a pre-surgical mri scan used for registration that did not meet the requirements for navigation, causing the 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 actual patient anatomy: the mri scan acquired 4 days before the surgery showed significant compression and skin shift due to a headrest or other restraint mechanism, also in areas where registration points were taken.Further, in the intervening time, there could have been a change in the patient's actual anatomy including the skin surface.The point acquisition by the user during patient registration was less than ideal with insufficient points acquired on unique bony areas on the patient's face, e.G.Not enough points were acquired on the tip of the nose, top of the head, left side of the head, and region of interest (right side) as required.A contributing factor that to a slight extent might have added to the deviation is a movement of the patient's head in the non-brainlab head holder and/or the navigation reference array due to insufficient rigid fixation or inadvertent forces at or after draping during the surgery.Apparently the extent of the resulting deviation of the navigation display was not detected by the user (despite acknowledging that the accuracy was less than optimal before and after the sterile draping of the patient) before performing the craniotomy and dissection path, with the necessary continued user verification of accuracy after draping and throughout the surgery.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.

• Brand Name: CRANIAL NAVIGATION SOFTWARE (VERSION 2.1)
• 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: 9449297
• MDR Text Key: 187240758
• Report Number: 8043933-2019-00062
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481000493
• UDI-Public: 04056481000493
• Combination Product (y/n): N
• PMA/PMN Number: K092467
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22214-02D
• Device Catalogue Number: 22214-02D
• Device Lot Number: SW V. 2.1.2.
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other