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

Model Number 22214-02D

Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Use of Device Problem (1670); Malposition of Device (2616); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2019

Event Type  Injury  

Manufacturer Narrative

Outcomes to adverse event, type of reportable event: 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 surgeon: there was no (direct or increased) risk to harm a critical brain structure (e. G. Blood vessels or important brain tissue) due to an actual biopsy resection or path actually applied. There were no negative clinical effects for this patient, and there was no prolongation of surgery / anesthesia. A revision surgery is planned to retrieve a diagnostic sample but not yet scheduled. There are no (other) remedial actions necessary, done or planned for this patient. There is a planned prolong of hospitalization only for the planned revision surgery. 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 remedial action initiated: 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 biopsy (diagnostic sample) of a brain tumor was performed with the aid of the brainlab navigation software cranial 2. 1. An mri scan was acquired pre-operatively on (b)(6) 2019 to use with navigation. Trajectory and registration points were planned on the scans pre-operatively in the brainlab navigation software the day of the surgery. During the procedure the surgeon: positioned the patient in a supine orientation in a non-brainlab head holder and attached the unsterile reference array. Performed the initial patient registration on the pre-op mri using the pointer acquiring 10 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 registration to proceed. Updated the planned entry point of the pre-planned trajectory using the pointer and the aid of navigation. Removed the unsterile navigation reference array and draped the patient. Attached a sterile reference array, re-verified navigation accuracy, and determined the burr hole placement with the aid of navigation. Attached and aligned the varioguide to the planned trajectory. Used the brainlab distributed (pajunk) biopsy needle inserted to the varioguide to collect tissue samples, which were sent to pathology for diagnosis. Completed the surgery. The tissue collected was determined to be non-diagnostic by pathology. A post-operative ct showed there was a 1cm deviation medially and laterally from the intended and planned target. The entry point was in the intended location. A revision surgery is planned but not yet scheduled. According to the surgeon: there was no (direct or increased) risk to harm a critical brain structure (e. G. Blood vessels or important brain tissue) due to an actual biopsy resection or path actually applied. There were no negative clinical effects for this patient, and there was no prolongation of surgery / anesthesia. A revision surgery is planned to retrieve a diagnostic sample but not yet scheduled. There are no (other) remedial actions necessary, done or planned for this patient. There is a planned prolong of hospitalization only for the planned revision surgery.

• 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
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer Contact: maura boyle ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 8704048
• MDR Text Key: 148177065
• Report Number: 8043933-2019-00033
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092467
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 22214-02D
• Device Catalogue Number: 71096
• Device Lot Number: SW V. 2.1.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 06/17/2019 Patient Sequence Number: 1