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); Insufficient Information (3190)

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

Event Date 05/20/2021

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since a craniotomy deviated from the desired location (and needed to be extended/corrected for surgery to be effective as intended), with the brainlab device involved, despite according to the surgeon there was no negative clinical effect to the patient, nor did the hospital/surgeon report any medical/surgical remedial action that would have been necessary, done or planned for this patient due to this issue. 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 resection of a cerebellar tumor has been performed with the aid of the brainlab navigation software cranial 4. 0. During the surgery, the patient was positioned prone and the neurosurgery registrar performed the registration of navigation to the preoperative scan using fiducials. The registrar planned the craniotomy using the aid of the display of navigation, and removed the bone flap. According to the surgeon, the location of the craniotomy was not in the intended location. The surgeon alleged that an inaccuracy in the display of navigation caused or contributed to the incorrect location of the craniotomy. The surgeon proceeded with the surgery by slightly 'refashioning' the craniotomy, with the size of the correction/enlargement deemed to be minimal, according to the surgeon. The surgeon completed the surgery successfully, using conventional methods and without the use of navigation. According to the surgeon, there was no actual harm or negative clinical effect to the patient due to this issue, although the surgeon stated there was an increased risk of harm due to the proximity of the location of the craniotomy to the sinus. There has been no report of any (further) medical/surgical remedial action that would have been necessary, done or planned for the patient due to this issue.

• 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 boyle ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 12016353
• MDR Text Key: 256715389
• Report Number: 8043933-2021-00045
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2020
• 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: 06/17/2021 Patient Sequence Number: 1