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

Model Number OPTICAL DISTANCE SENSOR

Device Problem Calibration Problem (2890)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2019

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

An error message appeared while calibrating the calibration plate.The laser button was turned off and on and the calibration was re-performed successfully.Of note, the laser had been turned off and on prior to the initial calibration as well.

Manufacturer Narrative

It was reported that an error message appeared while calibrating the calibration plate.The laser button was turned off and on and the calibration was re-performed successfully.According to technical investigation, the distance sensor failed to calibrate because its communication initialization with the pc failed at the first attempt of the user.The workflow was tested on manufacturing site but did not permit to reproduced the issue.Other tests were performed to find out whether the error could be reproduced, without success.However, the device behavior was reproduced and let us assume that the issue is related to the management of the laser button and might be a question of timing in the reception of commands.During the case, the laser button was restarted and the calibration could pass.Therefore, it also can be assumed there is no permanent hardware issue.The cause for the distance sensor initialization failure remains unknown.

Event Description

An error message appeared while calibrating the calibration plate.The laser button was turned off and on and the calibration was reperformed successfully.Of note, the laser had been turned off and on prior to the initial calibration as well.

• 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: 8943899
• MDR Text Key: 202027924
• Report Number: 3009185973-2019-00296
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPTICAL DISTANCE SENSOR
• 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: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1