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

Model Number ROSA ONE 3.1

Device Problems Connection Problem (2900); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2021

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.Unique identifier (udi) #: (b)(4).

Event Description

The robot would not connect to the controller the first try.The clinical representative (cr) opened an old patient folder to connect to the controller before the case started.The controller did not connect when the cr tried to initiate contactless registration.The software appeared to freeze and then eventually (>30 seconds after initiating controller connection) a windows error message popped up and stated that the rosannabrain.Exe software was not responding and asked if he would like to restart the program.Upon restart, the same thing happened.The software froze and the system never connected to the controller.At this point, the cr shutdown and unplugged the system for a minute or two.The cr restarted the system, opened the same patient folder and was able to connect the second time.There was no delay to the case and no patient involvement.

Event Description

The robot would not connect to the controller the first try.The clinical representative (cr) opened an old patient folder to connect to the controller before the case started.The controller did not connect when the cr tried to initiate contactless registration.The software appeared to freeze and then eventually (>30 seconds after initiating controller connection) a windows error message popped up and stated that the rosannabrain.Exe software was not responding and asked if he would like to restart the program.Upon restart, the same thing happened.The software froze and the system never connected to the controller.At this point, the cr shutdown and unplugged the system for a minute or two.The cr restarted the system, opened the same patient folder and was able to connect the second time.There was no delay to the case and no patient involvement.

Manufacturer Narrative

A full analysis of the data logs has been performed and concluded that both software freeze occurred when attempting to connect the arm for automatic registration and were due to a crash of the application.No other elements permit to determine the cause for the issue.

• 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: 11371715
• MDR Text Key: 244691628
• Report Number: 3009185973-2021-00050
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K200511
• 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: 03/19/2021

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 3.1
• Device Catalogue Number: ROSAS00203
• Device Lot Number: 3.1.4.1650
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 03/16/2021
• Supplement Dates FDA Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1