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

Model Number OPTICAL DISTANCE SENSOR (V3)

Device Problem Calibration Problem (2890)

Patient Problem No Patient Involvement (2645)

Event Date 10/09/2019

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

The company field service engineer (fse) was performing a preventive maintenance.During the brain accuracy checks, specifically during the check of the distance sensor (mt-02-183 s18106) the distance sensor didn't pass the test.He proceeded to check the distance sensor 4 more times because the results of the tests were close to passing.The final check that was performed had the results: xc=2.2 yc=1.5 and zc=2.6.During one of the many accuracy checks, while using kineverif, the robot had a communication failure and he had to manually restart the robot.This was during testing and not during a medical procedure.The distance sensor has since been removed from the robot.The fse plans on doing additional testing of the robot during the week of (b)(6) 2019.Everything else done during the preventative maintenance was a success.

Manufacturer Narrative

It was reported that on (b)(6) 2019, the optical distance sensor did not pass the accuracy test but the pointer probe did pass the accuracy and applicative tests.A capa was opened regarding optical distance sensors not passing the accuracy tests and one of the root causes identified is that the test was too sensitive.As a result, a new threshold was specified in the work instruction applicable since 26-may-2020.If the test involved in the subject report had been performed after 26-may-2020, the distance sensor would have been considered as accurate as per the new thresholds.Moreover, the maintenance performed on 25-may-2020 shows that the optical distance sensor passed the accuracy test.Therefore, the optical distance sensor is considered as accurate and functional, no replacement or repair is required.

Event Description

The company field service engineer (fse) was performing a preventive maintenance.During the brain accuracy checks, specifically during the check of the distance sensor ((b)(6)) the distance sensor didn¿t pass the test.He proceeded to check the distance sensor 4 more times because the results of the tests were close to passing.The final check that was performed had the results: xc=2.2 yc=1.5 and zc=2.6.During one of the many accuracy checks, while using kineverif, the robot had a communication failure and he had to manually restart the robot.This was during testing and not during a medical procedure.The distance sensor has since been removed from the robot.The fse plans on doing additional testing of the robot during the week of 14 october 2019.Everything else done during the preventative maintenance was a success.

• Brand Name: COMPUTER-ASSISTED SURGICAL DEVICE
• Type of Device: ROSA BRAIN
• Manufacturer (Section D): MEDTECH SA; zac eureka; 900 rue du mas de verchant; montpellier, languedoc-roussillon 34000 ; FR 34000
• MDR Report Key: 9284357
• MDR Text Key: 200853285
• Report Number: 3009185973-2019-00381
• 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
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: OPTICAL DISTANCE SENSOR (V3)
• Device Catalogue Number: ROSAS00316
• Device Lot Number: ROSA3-277B
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1