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

Model Number ROSA ONE

Device Problems Loss of Data (2903); Unintended Application Program Shut Down (4032)

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

Event Date 04/26/2021

Event Type  Injury  

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

Company representative (cr) was in hospital to support a bilateral seeg.Surgeon planed all 16 trajectories from brainlab burned in on rosa.When we tried to load the latest ct with fiducials rosanna crashed.After loading patient folder 4 trajectories were missing completely.1 was changed.Surgeon replanned the 5 trajectories and checked all others as well.(65 minutes delay).2 trajectories were really close to mayfield.Camenbert used to solve almost collision.When positioned on first 3 left trajectory, surgeon used axial mode to position.During this monitor went black.10 secondes.Later main menu to create/load folder or shut down appeared.After reloading folder, surgeon wanted to double check accuracy and planed a trajectory on a fiducial.Accuracy was ok.Rest of procedure went without issues.

Event Description

Company representative (cr) was in hospital to support a bilateral seeg.Surgeon planed all 16 trajectories from brainlab burned in on rosa.When we tried to load the latest ct with fiducials rosanna crashed.After loading patient folder 4 trajectories were missing completely.1 was changed.Surgeon replanned the 5 trajectories and checked all others as well.(65 minutes delay).2 trajectories were really close to mayfield.Camenbert used to solve almost collision.When positioned on first 3 left trajectory, surgeon used axial mode to position.During this monitor went black.10 secondes.Later main menu to create/load folder or shut down appeared.After reloading folder, surgeon wanted to double check accuracy and planed a trajectory on a fiducial.Accuracy was ok.Rest of procedure went without issues.

Manufacturer Narrative

A review of the dhr and of the complaint history for this device was performed and did not reveal any link with the subject complaint.A detailed analysis of the data logs has been performed.This analysis concluded that the first crash - when an exam was loaded from the pacs - occurred due to a software anomaly.Four trajectories were lost because the patient folder had not been saved before the crash.The final orientation tool was used for two trajectories in order to avoid a collision, which is a standard procedure.Then a second crash occurred due to a memory allocation issue.These issues will be addressed through the continuous improvement process of our product.Corrected data: b4 date of this report, g3 date received by manufacturer , h2 if follow-up, what type, h3 device evaluated by manufacturer, h6 adverse event problem, h10 additional narratives/data.

• 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: 11869223
• MDR Text Key: 252156466
• Report Number: 3009185973-2021-00134
• 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: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA ONE
• Device Catalogue Number: ROSAS00204
• Device Lot Number: 3.1.4.1652
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/24/2021
• Supplement Dates Manufacturer Received: 06/24/2021
• Supplement Dates FDA Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other