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

Model Number ROBOT STAND COMPUTER

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Patient Involvement (2645)

Event Date 01/19/2021

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

Company representative (cr) was present for an ablation case.When the cr arrived onsite, she attempted to turn on the robot, but it would not turn on.When the power switch was flipped on, the power button remained red.Cr tried to turn the power switch off and unplug the robot several times but had the same result.Cr also tried pressing and pressing/holding the power button without success.An inspection of the inside of the robot did not reveal any obvious problems ¿ no wiring issues were apparent and the back of the pc tower had a green light lit up.The surgeon was able to borrow the rosa one device from another hospital and bring it over.The case was performed using this robot without any problems.After the case, cr took the pc from the borrowed rosa one device and put it in the subject rosa one device.The robot booted up fine and connected to the controller without any problems.With this in mind, the cr diagnosed that the pc in the subject rosa one device was not working, despite receiving power.No patient involvement.

Event Description

Company representative (cr) was present for an ablation case.When the cr arrived onsite, she attempted to turn on the robot, but it would not turn on.When the power switch was flipped on, the power button remained red.Cr tried to turn the power switch off and unplug the robot several times but had the same result.Cr also tried pressing and pressing/holding the power button without success.An inspection of the inside of the robot did not reveal any obvious problems ¿ no wiring issues were apparent and the back of the pc tower had a green light lit up.The surgeon was able to borrow the rosa one device from another hospital and bring it over.The case was performed using this robot without any problems.After the case, cr took the pc from the borrowed rosa one device and put it in the subject rosa one device.The robot booted up fine and connected to the controller without any problems.With this in mind, the cr diagnosed that the pc in the subject rosa one device was not working, despite receiving power.No patient involvement.

Manufacturer Narrative

The pc alleged to be malfunctioning was returned to the manufacturing site for investigation.The testing of the robot pc concluded that it failed to turn on and needed to be replaced because the power supply was dysfunctional.

• 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: 11250368
• MDR Text Key: 229302282
• Report Number: 3009185973-2021-00029
• 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
• Type of Report: Initial,Followup
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ROBOT STAND COMPUTER
• Device Catalogue Number: ROSAS00194
• Device Lot Number: 3.1.4.1650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1