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 Consequences Or Impact To Patient (2199)

Event Date 02/03/2021

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

The clinical representative (cr) was present for an seeg case.After placing the electrodes, the surgeon had an intraoperative ct taken to confirm accuracy using the airo.The airo scan did not merge correctly with the automatic merge on the first try.The surgeon had to try to recalculate the merge several times before the rosa software was able to correctly merge the two scans.No delay to case, after first incision, patient was already under anesthesia, no patient impact.

Event Description

The clinical representative (cr) was present for an seeg case.After placing the electrodes, the surgeon had an intraoperative ct taken to confirm accuracy using the airo.The airo scan did not merge correctly with the automatic merge on the first try.The surgeon had to try to recalculate the merge several times before the rosa software was able to correctly merge the two scans.No delay to case, after first incision, patient was already under anesthesia, no patient impact.

Manufacturer Narrative

A full analysis of the data logs has been performed and this analysis concluded that the 'recalculate' function was pressed several times before achieving satisfying results, but the use of this function along with manual adjustments is a normal behavior when the automatic fusion does not give satisfying results.There was no failure detected, the device operated within specification.

• 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: 11322628
• MDR Text Key: 232267642
• Report Number: 3009185973-2021-00039
• 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: 02/16/2021

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: 02/03/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 02/15/2021
• Supplement Dates FDA Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1