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

Model Number OPTICAL DISTANCE SENSOR

Device Problem Calibration Problem (2890)

Patient Problem No Patient Involvement (2645)

Event Date 12/02/2019

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.(b)(4).

Event Description

After completing the reconfiguration of the br18 system as a result of the field action, the company field service engineer (fse) performed the brain accuracy checks and received a 'distance sensor failure' error message each time the distance sensor was loaded in kineverif.Therefore the distance center is unable to be calibrated and thus unable the accuracy check is unable to be completed.The error occurs immediately after turning on/off the laser.Some troubleshooting that has been tried includes: restarting the system multiple times, reinstalling the drivers and reinstalling the.Dat calibration file for the distance sensor onsite, checking the sick box values (it should be noted that the reading on the box does not change when putting on the calibration plate -always remains at 23.500) ¿ and none of these actions resolved the error.Additionally, when trying to use the laser in the rosa brain software, the following error occurs 'error while initializing the distance sensor switch off and back off the distance sensor before trying again.' this error continues to appear despite turning off/on the laser multiple times.The event occured during the reconfiguration of the system as a result of the field action.

Event Description

After completing the reconfiguration of the br18 system as a result of the field action, the company field service engineer (fse) performed the brain accuracy checks and received a "distance sensor failure" error message each time the distance sensor was loaded in kineverif.Therefore the distance center is unable to be calibrated and thus unable the accuracy check is unable to be completed.The error occurs immediately after turning on/off the laser.Some troubleshooting that has been tried includes: restarting the system multiple times, reinstalling the drivers and reinstalling the.Dat calibration file for the distance sensor onsite, checking the sick box values (it should be noted that the reading on the box does not change when putting on the calibration plate -always remains at 23.500) ¿ and none of these actions resolved the error.Additionally, when trying to use the laser in the rosa brain software, the following error occurs "error while initializing the distance sensor switch off and back off the distance sensor before trying again." this error continues to appear despite turning off/on the laser multiple times.The event occured during the reconfiguration of the system as a result of the field action.

Manufacturer Narrative

It was reported that during accuracy checks, the field service engineer received the message "distance sensor failure".The error kept coming despite several attempts to troubleshoot : - reinstalling the drivers, - reinstalling the.Dat calibration file for the distance sensor, - checking the sick box values.It can be concluded that the issue is not caused by a software issue.The optical distance sensor is no longer functional probably due to an electrical problem.A replacement was advised.The root cause of this malfunction cannot be determined as the device was not returned for investigation.This complaint will be closed as is, and will be reopened should further information be received in the future.

Event Description

After completing the reconfiguration of the br18 system as a result of the field action, the company field service engineer (fse) performed the brain accuracy checks and received a "distance sensor failure" error message each time the distance sensor was loaded in kineverif.Therefore the distance center is unable to be calibrated and thus unable the accuracy check is unable to be completed.The error occurs immediately after turning on/off the laser.Some troubleshooting that has been tried includes: restarting the system multiple times, reinstalling the drivers and reinstalling the.Dat calibration file for the distance sensor onsite, checking the sick box values (it should be noted that the reading on the box does not change when putting on the calibration plate -always remains at 23.500) ¿ and none of these actions resolved the error.Additionally, when trying to use the laser in the rosa brain software, the following error occurs "error while initializing the distance sensor switch off and back off the distance sensor before trying again." this error continues to appear despite turning off/on the laser multiple times.The event occured during the reconfiguration of the system as a result of the field action.

Manufacturer Narrative

The part has been received at the manufacturing site for further investigation.Corrected data: (b)(4).

Manufacturer Narrative

It was reported that during accuracy checks, the field service engineer received the messages 'distance sensor failure' and 'error while initializing the distance sensor switch off and back off the distance sensor before trying again.'.The error kept coming despite several attempts to troubleshoot : - reinstalling the drivers - reinstalling the.Dat calibration file for the distance sensor - checking the sick box values it can be concluded that the issue was not caused by a software issue.The damaged optical distance sensor was returned for investigation.It was able to connect with the kineverif application and with the robot software.The suspected root cause of this event was an electrical issue, but in order to confirm this hypothesis, the optical distance sensor extension cable was opened to be able to verify the electrical connections.It was confirmed that one of the electrical cables was detached on one side.The issues experienced will be addressed through the continuous improvement of our product in the preventative maintenance.

Event Description

After completing the reconfiguration of the br18 system as a result of the field action, the company field service engineer (fse) performed the brain accuracy checks and received a 'distance sensor failure' error message each time the distance sensor was loaded in kineverif.Therefore the distance center is unable to be calibrated and thus unable the accuracy check is unable to be completed.The error occurs immediately after turning on/off the laser.Some troubleshooting that has been tried includes: restarting the system multiple times, reinstalling the drivers and reinstalling the.Dat calibration file for the distance sensor onsite, checking the sick box values (it should be noted that the reading on the box does not change when putting on the calibration plate -always remains at 23.500) ¿ and none of these actions resolved the error.Additionally, when trying to use the laser in the rosa brain software, the following error occurs 'error while initializing the distance sensor switch off and back off the distance sensor before trying again.' this error continues to appear despite turning off/on the laser multiple times.The event occured during the reconfiguration of the system as a result of the field action.

• 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
• MDR Report Key: 9710721
• MDR Text Key: 202024416
• Report Number: 3009185973-2020-00046
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K182417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: OPTICAL DISTANCE SENSOR
• Device Catalogue Number: ROSAS00316
• Device Lot Number: ROSA3-277B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1