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

Model Number LAPTOP COMPUTER

Device Problem Patient Data Problem (3197)

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

Event Date 06/15/2021

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (b)(4).The information reported by the field service engineer led to the conclusion that the impossibility to transfer a patient folder from the planning station to the robot was related to the process of the change of password.This instruction was not correctly followed and led to an encryption issue.The field service engineer reinstalled windows and did a full renewed installation of the planning station while upgrading the software version.He then tested the feature of the patient folder transfer and confirmed that the problem was resolved.

Event Description

It was reported that in testing the connection required in procedure the clinical representative (cr) found that it was not possible to transfer a patient folder from the planning station to the robot on (b)(6) 2021.The root cause was an issue surrounding the planning station rosa brain (user profile) password.It seems that the process was not followed correctly to change the password on the planning station resulting in a corruption of the encryption.Following work instruction, the cr reinstalled windows and did a full renewed installation of the planning station with rosa 3.1.5.1664 software on (b)(6) 2021 during the planned preventative maintenance.The cr tested the capability and found the problem to be resolved.

• 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: 12108069
• MDR Text Key: 282049368
• Report Number: 3009185973-2021-00163
• 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
• Report Date: 07/02/2021

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: Other
• Device Model Number: LAPTOP COMPUTER
• Device Catalogue Number: ROSAS00369
• Device Lot Number: 3.1.4.1664
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2021
• Initial Date FDA Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1