MAUDE Adverse Event Report: BRAINLAB AG IPLAN STEREOTAXY SOFTWARE (VERSION 3.0.6); PLANNING SYSTEM, STEREOTACTIC INSTRUMENT

Model Number 21210I

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/10/2017

Event Type  malfunction  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since electrodes were placed in locations in the patient's brain different than planned with the brainlab navigation device involved, despite according to the surgeon: - there were no negative effects to the patient, neither due to electrode placements nor due to prolong of surgery/anesthesia (of ca.45 - 60 min) - there are no remedial actions, done or planned for this patient due to this issue at this moment.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 deviations of the actual positions of the electrodes from the planned positions is user error: user created a treatment plan containing multiple stereotactic references, at least one of them being invalidated (e.G.: being outdated or invalid due to changed patient position) and did not select/verify the correct stereotactic reference for creating stereotactic arc settings.The treatment plan ultimately contained two outdated stereotactic references in addition to one valid stereotactic reference.According to the information derived from the complaint questionnaire, user did neither define nor verify the correct stereotactic reference in the application further contributing factors: -user appears to be writing down partial information from the arc settings dialog on paper rather than printing the arc settings printout and striking through or marking information on the complete printout.-user appears to have lack of understanding about the interdependency of arc settings, stereotactic localizations and co-registrations.There is no indication of a systematic error or malfunction of the brainlab device.Corresponding brainlab measures to minimize this anticipated risk as low as reasonably practicable are already in place.Brainlab intends to re-iterate the relevant topics regarding the use of the device to this customer.

Event Description

This was a revision case using brainlab iplan stereotaxy 3.0.6 on a previous patient of dr.(b)(6) who had the original electrodes placed in (b)(6) 2016.Dr.(b)(6) pre-planned new trajectories using a new mri which he loaded into the old stereotaxy plan from the previous surgery.The day of the surgery: · a localization scan was performed, loaded into the plan and fused with the mri user had planned his trajectories on.User approved the fusion and continued to stereotactic planning and arc settings acquisition.First electrode placement: - user placed first electrode on the right side, removed the old one, and then proceeded to wake the patient up and do microelectrode testing which was deemed successful.User started placement of the left electrode when he noticed the headframe seemed loose.Upon investigation it was found one of the screws on the frame had become loose.Once that issue was resolved, dr.(b)(6) agreed that it would be best to perform another localization scan to verify nothing had been changed.Scan taken, imported, localized, fused to the original mri again, and then acquired the arc settings.No change was made to the settings by user.Second electrode placement: - user placed second electrode on the left side and removed the old one.Testing of this electrode was not successful and the patient complained of side effects - user decided to try again, this time he did not revise the trajectory in iplan, just used the microtargeting device to move the trajectory 2 mm lateral.Again, testing was not successful - user made third attempt and did adjust his trajectory in iplan this time and acquire new coordinates.Upon placement and testing, the patient began having stuttering speech and minor facial drooping.Immediately dr.(b)(6) removed the electrode and performed a half dose airo scan to check for bleeding.No bleeding showed up on the scan and the patient symptoms resolved themselves momentarily afterwards.Dr.(b)(6) decided to leave the second electrode out and close up.Dr.(b)(6) was asked by support to confirm the placement of the first electrode based on latest scan.He approved the image fusion and in review it was clear that the electrode and planned trajectory did not align placement of the 1st electrode was confirmed to be off plan using a half dose airo scan.The electrode was placed slightly laterally (1.5 mm) and about 7 mm deeper than intended from the trajectory.Due to the fact that the clinical microelectrode testing was successful, dr.(b)(6) decided to keep it in place and close anyway.According to the surgeon: - there were no negative effects to the patient, neither due to electrode placements nor due to prolong of surgery/anesthesia (of ca.45 - 60 min) - there are no remedial actions, done or planned for this patient due to this issue at this moment.Dr.(b)(6) is waiting for the results of this investigation to determine if he will try again to place the left electrode.

• Brand Name: IPLAN STEREOTAXY SOFTWARE (VERSION 3.0.6)
• Type of Device: PLANNING SYSTEM, STEREOTACTIC INSTRUMENT
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; munich, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; munich, 81829 ; GM 81829
• Manufacturer Contact: paul neil ; olof-palme-strasse 9; munich, 81829 ; GM 81829 ; 89 9915680
• MDR Report Key: 6611017
• MDR Text Key: 76665194
• Report Number: 8043933-2017-00013
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481000646
• UDI-Public: 04056481000646
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 21210I
• Device Catalogue Number: 21210I
• Device Lot Number: SW V. 3.0.6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2015
• 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