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

Model Number ROSA ONE 3.1

Device Problem Computer Software Problem (1112)

Patient Problem No Patient Involvement (2645)

Event Date 12/11/2020

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

During preventative maintenance, the contactless brain accuracy checks failed greater than the acceptable amount of attempts.The check was performed four times and failed every time.The logs will be saved in the customer events folder of date (b)(6) 2020.There was no patient involvement.Brain accuracy check with pointer probe passed.Brain applicative checks with contactless and marker registration both passed with acceptable accuracy.

Manufacturer Narrative

A full analysis of the data logs has been performed and this analysis concluded that the distance sensor did not pass the accuracy checks according to the applicable work instruction.However, the values were over 2.5 mm but under 3 mm.The threshold of the accuracy test was updated to 3 mm, with a distance sensor passing the applicative test, to align with the system specifications.The accuracy tests conditions for maintenance were updated through a capa.The correct applicable work instruction for this device was updated.

Event Description

During preventative maintenance, the contactless brain accuracy checks failed greater than the acceptable amount of attempts.The check was performed four times and failed every time.The logs will be saved in the customer events folder of date (b)(6) 2020.There was no patient involvement.Brain accuracy check with pointer probe passed.Brain applicative checks with contactless and marker registration both passed with acceptable accuracy.

• 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: 11053806
• MDR Text Key: 229167052
• Report Number: 3009185973-2020-00324
• 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: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• 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
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1