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

Model Number ROSA ONE

Device Problem Unintended Application Program Shut Down (4032)

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

Event Date 01/31/2022

Event Type  malfunction  

Event Description

It was reported that the company representative (cr) assisted the surgeon for an seeg case.Around 9:39am eastern time, the robot arm was in guidance mode going toward a trajectory when a loud click noise was heard, indicating there was a disconnection between the robot and controller.The cr noticed that the software restarted and was back to the main screen when this happened.The cr asked the surgeon if there was anything out of the ordinary they did when this occurred, but the surgeon stated 'no' and that it appeared to be 'random'.The patient folder was selected in the software and the plan was loaded back up.The delay was less than 5 minutes.But then around 10:05am eastern, another issue appeared that was possibly related to the shutdown.In guidance mode, when trying to drive the arm back to the intermediate position to go to the next trajectory, the cr noticed the arm was not cleared far enough from the head, so the stop button on the screen was pushed by the cr before a collision could occur.When the cr selected the option to 'clear the arm' to hopefully put the arm in 'free and fast' to clear, the tool installation screen would pop up to calibrate the force sensor, even though the instrument holder was already on.The cr only had the option to either 'undo' or 'start' the calibration, but the cr knew not to press 'start' due to the field action error.So when undo was pushed it went back to the options of either shutting down the robot, clear the arm (which would go back to the calibration screen), or continuing with the movement (which would collide with the leksell frame on the patients' head.After removing the dril adaptor and screw from the insrument holder, there was just enough room to clear to the arm by the leksell frame.Otherwise the only other option would have been to select 'shutdown' and then restart the software to hopefully clear the arm.The delay was another 5 minutes.The patient was under anesthesia and incision had been made.

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).

Manufacturer Narrative

A full analysis of the data logs has been performed and concluded that the first unexpected restart of the software occurred after a vigilance device failure in cooperative mode and is due to an incorrect commands handling.This issue will be addressed through the continuous improvement process of our products.It was confirmed that an unexpected empty calibration was requested after the specific workflow described in the complaint.The issue is due to a known software anomaly handled through zfa-2021-00198 (fda reference z-0118-2022).The workflow followed by the trained operator to work around the situation was correct.Corrected data: b4 date of this report g3 date received by manufacturer h2 if follow-up, what type h3 device evaluated by manufacturer h6 adverse event problem h7 remedial action h9 action reported to fda h10 additional narratives/data.

Event Description

It was reported that the company representative (cr) assisted the surgeon for an seeg case.Around 9:39am eastern time, the robot arm was in guidance mode going toward a trajectory when a loud click noise was heard, indicating there was a disconnection between the robot and controller.The cr noticed that the software restarted and was back to the main screen when this happened.The cr asked the surgeon if there was anything out of the ordinary they did when this occurred, but the surgeon stated 'no' and that it appeared to be 'random'.The patient folder was selected in the software and the plan was loaded back up.The delay was less than 5 minutes.But then around 10:05am eastern, another issue appeared that was possibly related to the shutdown.In guidance mode, when trying to drive the arm back to the intermediate position to go to the next trajectory, the cr noticed the arm was not cleared far enough from the head, so the stop button on the screen was pushed by the cr before a collision could occur.When the cr selected the option to 'clear the arm' to hopefully put the arm in 'free and fast' to clear, the tool installation screen would pop up to calibrate the force sensor, even though the instrument holder was already on.The cr only had the option to either 'undo' or 'start' the calibration, but the cr knew not to press 'start' due to the field action error.So when undo was pushed it went back to the options of either shutting down the robot, clear the arm (which would go back to the calibration screen), or continuing with the movement (which would collide with the leksell frame on the patients' head.After removing the dril adaptor and screw from the instrument holder, there was just enough room to clear to the arm by the leksell frame.Otherwise the only other option would have been to select 'shutdown' and then restart the software to hopefully clear the arm.The delay was another 5 minutes.The patient was under anesthesia and incision had been made.

• Brand Name: ROSA ONE
• Type of Device: COMPUTER-ASSISTED SURGICAL DEVICE
• Manufacturer (Section D): MEDTECH SAS; 432 rue du rajol; mauguio, languedoc-roussillon 34130 ; FR 34130
• Manufacturer (Section G): MEDTECH SAS; 432 rue du rajol; mauguio, languedoc-roussillon 34130 ; FR 34130
• Manufacturer Contact: jay sharma ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 13619702
• MDR Text Key: 288029388
• Report Number: 3009185973-2022-00015
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/19/2022

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 ONE
• Device Catalogue Number: ROSAS00203
• Device Lot Number: 3.1.5.28
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2022
• Initial Date FDA Received: 02/28/2022
• Supplement Dates Manufacturer Received: 04/19/2022
• Supplement Dates FDA Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0118-2022
• Patient Sequence Number: 1