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

Model Number ROSA ONE 3.1

Device Problem Data Problem (3196)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2020

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.(b)(4).

Event Description

The clinical representative (cr) assisted the surgeon an rns case on (b)(6) 2020.Before the case started, the surgeon mentioned to the cr that they experienced some issues loading the patient imaging the previous day (b)(6) 2020) onto the (b)(6) laptop.The surgeon stated that the imaging was attempted to be uploaded, but the progress stayed at zero percent for about ten minutes.After ten minutes, the surgeon removed the usb containing the patient imaging, and restarted the laptop.The surgeon attempted to load the imaging again the exact same way as before, but this time the imaging loaded quickly and worked fine.The cr loaded in the patient plan from the planning station to the robot to begin the case.Around 9:06am eastern time, the cr attempted to load in the bone fiducial ct imaging from a cd, to merge to the patient plan for registering.The cr experienced a similar imagery issue as to what the surgeon described from the day before.The cd imaging loaded into the rosa software, but when trying to load the needed series, it stayed at zero percent progress for a few minutes.The cr removed the usb, and tried again, but got the same result.The cr then tried the workaround of selecting the series through pacs/iq-view, and scanning/loading in the selected series from there.Once that was loaded into the rosa software, the series was selected to be loaded in, but this time it loaded quickly and correctly with no issue.The imaging was merged and surgery was continued.The patient was under anesthesia and no incision was made yet.The total delay was less than 30 minutes.

Manufacturer Narrative

A full analysis of the data logs has been performed and this analysis concluded that the failure to load the exam from the cd during the case was most likely due to the fact that the user removed the cd before it could be loaded.This exam was a heavy file, so it would have taken a few minutes to load from the cd.The progress staying at zero percent for several minutes is not a malfunction of the device.However, since it can be misleading for the user, a software anomaly has been opened as an improvement opportunity.The first issue regarding a failure to load an exam on the planning station could not be confirmed with the available data.

Event Description

The clinical representative (cr) assisted the surgeon an rns case on (b)(6) 2020.Before the case started, the surgeon mentioned to the cr that they experienced some issues loading the patient imaging the previous day (b)(6) 2020) onto the rosa laptop.The surgeon stated that the imaging was attempted to be uploaded, but the progress stayed at zero percent for about ten minutes.After ten minutes, the surgeon removed the usb containing the patient imaging, and restarted the laptop.The surgeon attempted to load the imaging again the exact same way as before, but this time the imaging loaded quickly and worked fine.The cr loaded in the patient plan from the planning station to the robot to begin the case.Around 9:06am eastern time, the cr attempted to load in the bone fiducial ct imaging from a cd, to merge to the patient plan for registering.The cr experienced a similar imagery issue as to what the surgeon described from the day before.The cd imaging loaded into the rosa software, but when trying to load the needed series, it stayed at zero percent progress for a few minutes.The cr removed the usb, and tried again, but got the same result.The cr then tried the work around of selecting the series through pacs/iq-view, and scanning/loading in the selected series from there.Once that was loaded into the rosa software, the series was selected to be loaded in, but this time it loaded quickly and correctly with no issue.The imaging was merged and surgery was continued.The patient was under anesthesia and no incision was made yet.The total delay was less than 30 minutes.

• 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: 10800108
• MDR Text Key: 215015886
• Report Number: 3009185973-2020-00295
• 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: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• 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: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1