MAUDE Adverse Event Report: BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 3.0) IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number 22216

Device Problems Image Display Error/Artifact (1304); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 10/30/2018

Event Type  Death  

Manufacturer Narrative

With the currently available information, brainlab can neither exclude nor confirm that the brainlab device or its use caused or contributed to the death of the patient. 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 upon completion of investigation.

Event Description

A right frontal burr hole and endoscopic (e. G. Direct visualization) resection of colloid cyst of 3rd ventricle with a stereotactic approach was performed with the aid of brainlab navigation system cranial 3. 0. During the procedure the surgeon: performed an intraoperative ct scan using a non-brainlab ct scanner and accepted the automatic registration of the current patient anatomy to the navigation (to the intra-operative ct scan imported into and used by the navigation). Created a burr hole, and passed a sheath through the burr hole. Used the navigated brainlab pointer during the surgery with the sheath. Used a non-navigated non-brainlab endoscope through this sheath. At some point during the surgery, the surgeon detected a deviation of the display of navigation compared to the patient's anatomy. On (b)(6) 2020 brainlab was informed the patient died following complications, when brainlab received a request from the coroner for a report.

• Brand Name: CRANIAL NAVIGATION SOFTWARE (VERSION 3.0)
• 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: 9653107
• MDR Text Key: 177166430
• Report Number: 8043933-2020-00007
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K092467
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 22216
• Device Catalogue Number: 22216
• Device Lot Number: SW V. 3.0
• Was Device Available for Evaluation?: Yes

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• 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: 01/31/2020 Patient Sequence Number: 1