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

Model Number ROSA BRAIN

Device Problem Unintended Collision (1429)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2019

Event Type  malfunction  

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.

Event Description

Two separate collisions were responsible for multiple shutdowns.The first occurred during registration when the cord of the force sensor was pinched while collecting points in cooperative mode.The robot was restarted, but the position of the cord immediately forced another shutdown.The second collision occurred after registration when attempting to mark an entry point with the distance sensor.The collision was between the robotic arm and the telescopic arm (no patient contact or harm occurred).Rosa was restarted multiple times in an attempts to move the arm but ultimately it was necessary to use the manual release of the arm.The only impact to the surgery was the loss of time required for restarts which totaled <30 min.

Event Description

Two separate collisions were responsible for multiple shutdowns.The first occurred during registration when the cord of the force sensor was pinched while collecting points in cooperative mode.The robot was restarted, but the position of the cord immediately forced another shutdown.The second collision occurred after registration when attempting to mark an entry point with the distance sensor.The collision was between the robotic arm and the telescopic arm (no patient contact or harm occurred).Rosa was restarted multiple times in an attempts to move the arm but ultimately it was necessary to use the manual release of the arm.The only impact to the surgery was the loss of time required for restarts which totaled <30 min.

Manufacturer Narrative

An analysis of the data logs from the subject event has been performed.This analysis concluded that the first communication error was due to the force sensor cable pinched.It prevented two joints of the robot arm to move freely then, the shutdown was a normal behavior of the device, it worked as expected.When the robot arm was restarted, a second communication failure occurred most likely due to the position of the force sensor cord which was still pinched.However, this possible root cause cannot be confirmed as the error was not recorded in the log controller.The third communication issue was due to a robot arm collision with the support arm.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.Then, three others communication failures were detected, at the arm connection, due to the previous collision.The arm was likely still in contact with the support arm, that is why the controller detected a default situation on the axis previously involved in collision.This event caused the shutdown of the device which is a normal behavior.The last communication error, not mentioned in the complaint description, occurred during a clearance procedure due to the force applied on the robot arm which were close to a singularity.Therefore, the shutdown was a normal behavior of the device.Corrected data: - b4 date of this report - g4 date received by manufacturer - h2 if follow-up, what type - h3 device evaluated by manufacturer - h6 event problem and evaluation codes - h10 additional narratives/data.

• 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: 9494045
• MDR Text Key: 198740479
• Report Number: 3009185973-2019-00459
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K151359
• 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: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 02/06/2020
• Supplement Dates FDA Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1