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); Improper or Incorrect Procedure or Method (2017)

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

Event Date 11/28/2022

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since biopsied tissue samples were collected in a different location in the brain than anticipated, with the brainlab device involved, despite according to the hospital: the outcome of the surgery was successful as intended (diagnostic biopsy obtained during this same surgery).There was an increased risk of harm due to the incorrect samples collected from the cerebellum but there was no report of any actual harm or negative clinical effect to the patient due to the biopsy samples collected at this surgery.There was no harm due to the prolonged anesthesia of 1.5 hours.There was no report of any further remedial medical or surgical actions that were necessary, done, or planned for this patient.There was no report of any prolonged hospitalization either.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 inaccurate location of the biopsy, done with the aid of navigation, at the target by approximately 20 mm was an insufficient distribution of registration points acquired by the user for patient anatomy registration to the preoperative scan used for navigation.Specifically, not many points were acquired on unique anatomical landmarks such as side or tip of the nose.This caused the cranial navigation software to not find an as accurate match in the region of interest as desired for this specific procedure in between the preoperative image dataset and the actual patient anatomy.As a potential contributing factor, a movement of the patient's head and/or patient reference array due to a non-rigid fixation and/or inadvertent forces applied after patient registration but before marking the region of interest cannot be completely ruled out.A movement of the patient's head relative to the reference array or vice versa cannot be compensated by the navigation system and can result in a deviation between the registered patient image and the actual patient.Apparently the resulting deviation of the navigation display was not recognized by the user with the necessary navigation accuracy verification after registration, and throughout the procedure, and after draping, before the performing the biopsy.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 Description

A cranial surgery for diagnostic biopsy of a lesion of approximately 15mm diameter located at a depth of about 55mm in the cerebellum, was performed with the aid of the display by the brainlab navigation software cranial 3.1.A pre-operative mri was acquired five days prior to the surgery for use with navigation.During the procedure the surgeon: positioned the patient prone in a non-brainlab headholder and attached the unsterile navigation reference.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 the registration and accepted the result to proceed.Used the navigated pointer to mark the intended entry point on the patient's skin and draped the patient, removing the unsterile navigation reference, and attached the sterile navigation reference.Verified the accuracy of the navigation again and did not detect any deviation from the sterile draping process.Made the skin incision and created a burr hole in the skull at the predetermined entry point using a non-navigated drill.Aligned the brainlab frameless biopsy system over the burr hole and in line with the intended target (center of the lesion).Passed the navigated biopsy needle through the frameless biopsy system down to the intended target and collected 4 samples at a single location in the lesion.Submitted the samples to the hospital pathology department who returned results that the samples were healthy tissue (non-diagnostic).Performed an intraoperative mri scan and observed the location of the biopsy: it was determined that the angle of the needle was correct but the depth of the actual biopsy was superficial to the intended target by approx.20mm.Performed another pass of the biopsy needle at an increased depth along the same trajectory, and collected another 4 samples, which were confirmed to be diagnostic by pathology.Completed the surgery.According to the hospital: the outcome of the surgery was successful as intended (diagnostic biopsy obtained during this same surgery).There was an increased risk of harm due to the incorrect samples collected from the cerebellum but there was no report of any actual harm or negative clinical effect to the patient due to the biopsy samples collected at this surgery.There was no harm due to the prolonged anesthesia of 1.5 hours.There was no report of any further remedial medical or surgical actions that were necessary, done, or planned for this patient.There was no report of any prolonged hospitalization either.

• 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
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer Contact: maura pascarella ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 16028959
• MDR Text Key: 305974143
• Report Number: 8043933-2022-00068
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other