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).

• 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: andrea miller ; 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
• Reporter Country Code: UK
• PMA/PMN Number: K192703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 22216-02B
• Device Catalogue Number: 22216-02B
• Device Lot Number: SW V. 3.1
• 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: 09/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 09/29/2021 Patient Sequence Number: 1