MAUDE Adverse Event Report: MEDTECH SA ROSA BRAIN; COMPUTER-ASSISTED SURGICAL DEVICE

Model Number ROSA BRAIN 3.0

Device Problems Mechanical Problem (1384); Unintended Collision (1429)

Patient Problem No Code Available (3191)

Event Date 05/07/2019

Event Type  Injury  

Manufacturer Narrative

The device has not been evaluated yet for investigation purpose.Once the evaluation is performed, a follow-up medwatch report will be submitted. (b)(4).The surgery was delayed by an hour.

Event Description

Two field service engineers (fse) were present for an seeg case at (b)(6).Surgical plan involved 17 total trajectories with bilateral placement.Patient was pinned fairly close to some trajectories, and fses discussed this risk with the surgeon before pinning and moving forward with the case.During the 3rd to last trajectory, robot moved to the trajectory, but the arm could not be pushed so that the adaptor would be flush with the skin due to the mayfield adaptor being in the way.The surgeon requested to send the arm in from a modified angle so that it could come over the top of the mayfield adaptor and be pushed closer in to the patient¿s head.The fse sent the arm back to the intermediate position and modified the angle of approach for the arm in what she thought was the appropriate direction.However, the angle chosen turned out to modify the trajectory in the wrong direction, and the mayfield adaptor was still in the way of the arm.As the arm was still automatically navigating to its position, it collided with the mayfield holder, causing a communication failure and shutdown of the robot.The fse attempted a manual release of the robot, however, the arm would not move at any joints when the knob was turned to the correct joint and the button pressed.Patient had to be detached from the robot so that the arm could be brought back to home position, and registration had to be performed again.

Manufacturer Narrative

It was reported that a collision occurred during the surgery and then the manual break release did not work.A dhr review and a complaint history review was performed and did not identify any contributory factors to the event.Analysis of data logs determined that collision is due to use error.Indeed the ifu provides details on how to manage the vigilance device pedal.The 1st communication error is a consequence of the previous collision.Then, the arm could not be moved because it was already powered off therefore it is considered as not a confirmed failure.Finally a 2nd communication error occurred due to unknown root cause as controller logs did not record the error.(b)(6).

Event Description

Two field service engineers (fse) were present for an seeg case at stanford university.Surgical plan involved 17 total trajectories with bilateral placement.Patient was pinned fairly close to some trajectories, and fses discussed this risk with the surgeon before pinning and moving forward with the case.During the 3rd to last trajectory, robot moved to the trajectory, but the arm could not be pushed so that the adaptor would be flush with the skin due to the mayfield adaptor being in the way.The surgeon requested to send the arm in from a modified angle so that it could come over the top of the mayfield adaptor and be pushed closer in to the patient¿s head.The fse sent the arm back to the intermediate position and modified the angle of approach for the arm in what she thought was the appropriate direction.However, the angle chosen turned out to modify the trajectory in the wrong direction, and the mayfield adaptor was still in the way of the arm.As the arm was still automatically navigating to its position, it collided with the mayfield holder, causing a communication failure and shutdown of the robot.The fse attempted a manual release of the robot, however, the arm would not move at any joints when the knob was turned to the correct joint and the button pressed.Patient had to be detached from the robot so that the arm could be brought back to home position, and registration had to be performed again.(b)(6).

Manufacturer Narrative

This follow up report is submitted to correct the udi number provided in the initial report.(b)(4).

Event Description

Two field service engineers (fse) were present for an seeg case at stanford university.Surgical plan involved 17 total trajectories with bilateral placement.Patient was pinned fairly close to some trajectories, and fses discussed this risk with the surgeon before pinning and moving forward with the case.During the 3rd to last trajectory, robot moved to the trajectory, but the arm could not be pushed so that the adaptor would be flush with the skin due to the mayfield adaptor being in the way.The surgeon requested to send the arm in from a modified angle so that it could come over the top of the mayfield adaptor and be pushed closer in to the patient¿s head.The fse sent the arm back to the intermediate position and modified the angle of approach for the arm in what she thought was the appropriate direction.However, the angle chosen turned out to modify the trajectory in the wrong direction, and the mayfield adaptor was still in the way of the arm.As the arm was still automatically navigating to its position, it collided with the mayfield holder, causing a communication failure and shutdown of the robot.The fse attempted a manual release of the robot, however, the arm would not move at any joints when the knob was turned to the correct joint and the button pressed.Patient had to be detached from the robot so that the arm could be brought back to home position, and registration had to be performed again.

• Brand Name: ROSA BRAIN
• Type of Device: COMPUTER-ASSISTED SURGICAL DEVICE
• Manufacturer (Section D): MEDTECH SA; zac eureka; 900 rue du mas de verchant; montpellier, languedoc-roussillon 34000 ; FR 34000
• MDR Report Key: 8614832
• MDR Text Key: 145213616
• Report Number: 3009185973-2019-00177
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K172444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA BRAIN 3.0
• Device Catalogue Number: ROSA BRAIN
• Device Lot Number: 3.0.0.21
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 05/16/2019
• Supplement Dates Manufacturer Received: 06/20/2019; 07/31/2019
• Supplement Dates FDA Received: 07/15/2019; 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other