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

Model Number LAPTOP COMPUTER

Device Problems Computer Software Problem (1112); Data Problem (3196)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

Udi#: unknown.The device has not been evaluated yet for investigation purpose.Once the evaluation is performed, a follow-up medwatch report will be submitted.

Event Description

The pla, could not be transferred over to a usb.Two usbs were tried, including one that was newly formatted and empty; however, an error message appeared saying the plan could not be transferred.Maintenance mode was access to transfer the plan directly from the patient folder.This occurred prior to the patient being in the room and caused no delay to the surgery.

Manufacturer Narrative

A full analysis of the data logs has been performed and concluded that the issue is similar to a known software anomaly.The patient folder analyzed is the patient folder from the planning station.However, the files that were in the temporary folder could not be analyzed.It is possible that the files from the temporary folder were in read only mode, and the files of the patient folder from the planning station were not.This would explain why the copy failed.However, in this case, the data did not permit to confirm this software anomaly.

Event Description

The patient folder, could not be transferred over to a usb.Two usbs were tried, including one that was newly formatted and empty; however, an error message appeared saying the plan could not be transferred.Maintenance mode was access to transfer the plan directly from the patient folder.This occurred prior to the patient being in the room and caused no delay to the surgery.

• 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: 11155580
• MDR Text Key: 232587154
• Report Number: 3009185973-2021-00007
• 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: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LAPTOP COMPUTER
• Device Catalogue Number: ROSAS00369
• Device Lot Number: 3.1.4.1650
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1