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

Model Number ROSA ONE 3.1

Device Problem Unintended Application Program Shut Down (4032)

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

Event Date 05/19/2021

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi) #: (b)(4).A full analysis of the data logs and patient folder has been performed and this analysis concluded that the main hypothesis is that an error occurred with the distance sensor and provoked the first restart.Then, after the first restart, the distance sensor stayed in an error state and provoked a second communication error between the controller and the sensor.This second communication error led to the second restart of the device.The root cause of the error remains unknown, the error that occurred is either a communication channel error between the distance sensor and the controller or an error of the sicksensor that includes the distance sensor.

Event Description

Marker registration was done and got an rms of 0.37.The clinical representative (cr) went to drive the robot to mark the entry points with the laser.The cr was able to plug in the laser and press the button on the back of the robot, but as soon as the calibration screen would normally come up, the computer restarted.The echo touch screen solutions screen came up and continued with the restart process and brought the cr back to the log in screen.The cr navigated back to the patient folder and went through the process of connecting the laser a second time and the exact same event happened.The surgeon decided to try to mark the entry with the pointer instead and did not have any issues occur.

• 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: 11981832
• MDR Text Key: 255689898
• Report Number: 3009185973-2021-00136
• 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,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA ONE 3.1
• Device Catalogue Number: ROSAS00203
• Device Lot Number: 3.1.5.1664
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2018
• 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