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

Model Number ROSA ONE 3.1

Device Problem Image Display Error/Artifact (1304)

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

Event Date 03/08/2021

Event Type  malfunction  

Manufacturer Narrative

A full analysis of the data logs has been performed and this analysis concluded that the recalculate function was used following manual adjustments, as expected, but was unsuccessful since manual adjustments were still needed.This is a known software anomaly that will be addressed through our design issues management process.The user had the possibility to undo the result to get back to his previous manual adjustments performed instead of restarting the merge from scratch.Unique identifier (udi) #: (b)(4).

Event Description

The clinical representative (cr) was present for an seeg case.During the case, cr loaded in an airo ct ('airo pre') after placing fiducials for registration.After placing electrodes, two scans were taken post-operative before and after disconnecting the rosa to confirm placement accuracy ('airo post' and 'airo post2').'airo post' cut off part of the patient¿s head in the scan, which is why a 2nd postoperative scan was taken after disconnecting the rosa.All 3 scans were merged to the preoperative ct, but did not merge accurately using the automatic merge and had to be manually adjusted and recalculated.Even after recalculating, all scans were manually adjusted to further improve accuracy.Delay to case about 5 mins, no patient impact, patient was already under anesthesia and after first incision.

• 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
• Manufacturer (Section G): MEDTECH SA; zac eureka; 900 rue du mas de verchant; montpellier, languedoc-roussillon 34000 ; FR 34000
• Manufacturer Contact: jay sharma ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 11567323
• MDR Text Key: 242165826
• Report Number: 3009185973-2021-00072
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• 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: 03/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1