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

Model Number ROSA ONE

Device Problem Loss of Data (2903)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2020

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

The following event occurred during a dbs case: before the case started, the surgeon was planning his two trajectories for the dbs leads.While loading in a new scan in iq-view, the software restarted.At this point the patient folder had been saved, however with the restart, the folder was wiped from the robot (there was no folder present on the import side of the software).The surgeon had to restart planning and load images in to the software again, causing approximately a 10 min delay.

Manufacturer Narrative

A full analysis of the data logs has been performed and revealed that both reported events were due to known software anomalies: issue when loading in a new scan in iqview.Patient folder disappearing from the robot due to the fact that there was an empty field in the patient file (.Ros).No consequence for the patient other than the short delay reported.Corrected data: b4 date of this report.G4 date received by manufacturer.H2 if follow-up, what type.H3 device evaluated by manufacturer.H6 event problem and evaluation codes.H10 additional narratives/data.

Event Description

The following event occurred during a dbs case: before the case started, the surgeon was planning his two trajectories for the dbs leads.While loading in a new scan in iqview, the software restarted.At this point the patient folder had been saved, however with the restart, the folder was wiped from the robot (there was no folder present on the import side of the software).The surgeon had to restart planning and load images in to the software again, causing approximately a 10 min delay.

• 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: 10534097
• MDR Text Key: 206949899
• Report Number: 3009185973-2020-00210
• 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: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA ONE
• 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: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1