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

Model Number ROSA BRAIN

Device Problem Unintended Collision (1429)

Patient Problem No Code Available (3191)

Event Date 08/12/2019

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).Unique identifier (udi) #: (b)(4).

Event Description

Field service engineers (fse) were present to assist a surgery.The first event occurred under the rosa guidance tab.Surgeons placed the skull clamp in a position where the structure of the skull clamp does not interfere with the trajectories planned.However, the skull clamp position did make it difficult to approach with the rosa arm on the left side of the patient¿s head.Once the rosa arm was driven to the first trajectory, it was clear that there was a high risk of collision.The rosa arm¿s movements were stopped.The plan was then to change the instrument length of the first trajectory to a bigger value so that he rosa arm can approach the entry point at a further distance away.The fse selected the options 'axial' and 'slow' for the surgeon to began clearing the rosa arm from the patient¿s head.The fse then changed the selection to 'free' and 'fast' in cooperative mode once the rosa arm was backed away at a reasonable distance from the skull clamp.However, the surgeon struggled with the control of the rosa arm.He accidentally drove it back towards the skull clamp and collided with it.The rosa robot detected a collision and shutdown as a result.Due to the position of the rosa arm after collision, the rosa arm was able to connect but would shut down immediately before the cooperative mode was available.The fse ended up performing a manual release and rebooting the rosa, which delayed the surgery case approximately 25 minutes.The fse pointed out to the surgeons that he saw the collision caused the skull clamp to move and that the surgeons should re-register because of this event.The surgeons disagreed, but after driving to a couple of different trajectories, it was visible that the trajectories was off because the distal end of the drill adaptor did not match up with the originally marked entry points.Contactless registration was redone.The second event occurred under the cooperative mode portion of rosa guidance.The surgeon was ready to clear the rosa arm from the patient¿s head and move it to the next trajectory.The fse set the rosa arm on axial and slow for the initial backing away movement.He then changed it to 'axial' and 'fast.' as the surgeon continued to clear the rosa arm from the patient¿s head, the rosa arm straightened out, an audible click was heard from the components within the rosa robot, an error screen showed up on the monitor and the rosa robot proceeded to shut down.The rosa robot was rebooted and this event delayed the surgery case 6 minutes.

Event Description

Field service engineers (fse) were present to assist a surgery.The first event occurred under the rosa guidance tab.Surgeons placed the skull clamp in a position where the structure of the skull clamp does not interfere with the trajectories planned.However, the skull clamp position did make it difficult to approach with the rosa arm on the left side of the patient¿s head.Once the rosa arm was driven to the first trajectory, it was clear that there was a high risk of collision.The rosa arm¿s movements were stopped.The plan was then to change the instrument length of the first trajectory to a bigger value so that he rosa arm can approach the entry point at a further distance away.The fse selected the options 'axial' and 'slow' for the surgeron to began clearing the rosa arm from the patient¿s head.The fse then changed the selection to 'free' and 'fast' in cooperative mode once the rosa arm was backed away at a reasonable distance from the skull clamp.However, the surgeon struggled with the control of the rosa arm.He accidentally drove it back towards the skull clamp and collided with it.The rosa robot detected a collision and shutdown as a result.Due to the position of the rosa arm after collision, the rosa arm was able to connect but would shut down immediately before the cooperative mode was available.The fse ended up performing a manual release and rebooting the rosa, which delayed the surgery case approximately 25 minutes.The fse pointed out to the surgeons that he saw the collision caused the skull clamp to move and that the surgeons should re-register because of this event.The surgeons disagreed, but after driving to a couple of different trajectories, it was visible that the trajectories was off because the distal end of the drill adaptor did not match up with the originally marked entry points.Contactless registration was redone.The second event occurred under the cooperative mode portion of rosa guidance.The surgeon was ready to clear the rosa arm from the patient¿s head and move it to the next trajectory.The fse set the rosa arm on axial and slow for the initial.Backing away movement.He then changed it to 'axial' and 'fast.' as the surgeon continued to clear the rosa arm from the patient¿s head, the rosa arm straightened out, an audible click was heard from the components within the rosa robot, an error screen showed up on the monitor and the rosa robot proceeded to shut down.The rosa robot was rebooted and this event delayed the surgery case 6 minutes.

Manufacturer Narrative

It was reported that there was a robot arm collision with the skull clamp.Due to the position of the robot arm, the device would always shut down, so a manual release was performed.Later on, there device did shut down.Event summary, device history record review and complaint history review did not identify contributing factors.A review of the log files was performed.A first communication error occurred in guidance, due to a collision of the robot arm with a skull clamp.It could have been avoided by releasing the pedal, as explained in the user manual therefore, the issue can be considered as a use error.Two others communication failures were detected, at the arm connection, due to the previous collision as the arm was likely still in contact with the skull clamp.This event caused the shutdown of the device which is a normal behavior.The last communication error, that occurred when the cooperative mode was activated in axial mode, due to the arm position which was out of limits.As a security, the device was set to stop when the robot arm position is out of limitation.Therefore, the device works as expected and the event described in the complaint description cannot be considered as an issue.

• 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: 8968560
• MDR Text Key: 157168553
• Report Number: 3009185973-2019-00300
• 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
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA BRAIN
• Device Catalogue Number: N/A
• Device Lot Number: 3.0.0.21
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1