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

Model Number ROSA ONE

Device Problems Application Program Freezes, Becomes Nonfunctional (4031); Intermittent Communication Failure (4038)

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

Event Date 04/27/2021

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

Event Description

It was reported that during an seeg case the controller disconnected.This occurred after contactless registration was completed and the arm was positioned at the first trajectory.Then upon restart, the controller failed to move to park position after the weight was calibrated.This repeated several times.Then, after several reboots, the sign on screen froze and the system needed to be powered down again.After the next reboot, and sign into maintenance user, the computer froze again, requiring another reboot.After restart, user was able to use kineverif to park rosa arm.Rosa brain software was then reopened and case was able to proceed without any further issue.Delay to case was under 30 minutes.

Manufacturer Narrative

A full analysis of the device data logs has been performed.When starting guidance the controller disconnected.Restarting the software multiple times did not solve the issue and the arm was unable to move to parking position.The event as described was confirmed.An error in the force sensor during guidance provoked the software restart and the shutdown of the controller due to a software anomaly.Although the error is detected as a communication failure, the application is turned off without indicating the user the origin of the stop.A software anomaly was recorded to refer the lack of communication with the user.After rebooting, the system failed to launch the cooperative mode in order to clear the arm.It was determined that the robotic software failed to initialize network card connected to the robot controller due to a software anomaly.Therefore, it was not able to communicate with the robot controller.It is confirmed that two system restarts occurred after unexpected system stops.However, the cause for these issues cannot be determined due to insufficient information.It was also found that the operating system experienced three timer error which provoked an inconsistent timeline on the event log which occurred thereafter.The cause for this issue could not be confirmed.

Event Description

It was reported that during an seeg case the controller disconnected.This occurred after contactless registration was completed and the arm was positioned at the first trajectory.Then upon restart, the controller failed to move to park position after the weight was calibrated.This repeated several times.Then, after several reboots, the sign on screen froze and the system needed to be powered down again.After the next reboot, and sign into maintenance user, the computer froze again, requiring another reboot.After restart, user was able to use kineverif to park rosa arm.Rosa brain software was then reopened and case was able to proceed without any further issue.Delay to case was under 30 minutes.

• Brand Name: ROSA ONE
• 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
• Manufacturer (Section G): MEDTECH SA; zac eureka; 900 rue du mas de verchant; montpellier, languedoc-roussillon 34000 ; FR 34000
• Manufacturer Contact: jay sharma ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 11885361
• MDR Text Key: 252705107
• Report Number: 3009185973-2021-00140
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA ONE
• Device Catalogue Number: ROSAS00203
• Device Lot Number: 3.1.4.1650
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1