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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2020

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

Vigilance device error noted in logs unforced restarts encountered during case.

Event Description

Vigilance device error noted in logs unforced restarts encountered during case.

Event Description

Vigilance device error noted in logs unforced restarts encountered during case.

Manufacturer Narrative

A full analysis of the data logs has been performed and the analysis confirmed that several vigilance device switches errors occurred during the case.This can be due to an incorrect wiring or a dysfunctional vigilance device.The vigilance device was replaced by a new one in order to prevent any other issues of the vigilance device.Regarding the first shutdown, an error occurred with the controller due to a loss of power.It triggered an error of the controller and led to a forced shutdown of the device.The cause of the loss of power remains undetermined.Regarding the second shutdown, a force sensor timeout occurred and led to the shutdown of the complete device.The main hypothesis for the second shutdown is that a connection issue occurred but it is not possible to confirm the hypothesis.A preventive maintenance was performed afterwards on the (b)(6) 2020 and confirmed that the device was functional.

• 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: 11055053
• MDR Text Key: 223600474
• Report Number: 3009185973-2020-00326
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K192173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2021

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: 12/04/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 05/21/2021; 05/21/2021
• Supplement Dates FDA Received: 05/21/2021; 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1