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

Model Number ROSA ONE

Device Problem Image Display Error/Artifact (1304)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2021

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 (crà was present for a biopsy and ablation case.The surgeon positioned the patient prone using a regular mayfield and attached to the rosa.The surgeon then placed fiducials and got an o-arm spin (first generation) of the fiducials for registration.When cr went to load the scan into the rosa using a usb, the merge screen showed that some of the slices had been cut out, so that there was a strange jump in bone at the top of the head.When loading in the scan, the cr had received an error that there were gaps between slices.Cr thought that the scan had not copied correctly onto the usb, and so pulled the same exam from pacs.Cr confirmed that 191 slices were present in the exam in the iqview temporary folder.However, the same problem occurred on the merge screen, but the cr did not receive any errors this time from the rosa software.The surgeon noted that the patient had hardware from a shunt located at the same level where the slices seemed to jump.The surgeon decided to get another scan and tilt the gantry of the o-arm slightly to allow for clear visualization of the fiducials below the problem area.The 2nd scan was transferred by usb to the robot and gave the same error that there were gaps between slices.It also showed the same jump between slices as the first scan.The surgeon decided to try to proceed with registration because he felt that the merge below the problem area was accurate and included all of the fiducials.Registration was performed without issue and an rms of 0.62 was achieved.After verification, the surgeon felt comfortable to proceed with the biopsy and laser fiber placement.Before detaching from the rosa, the surgeon got another o-arm scan with the laser fiber in place, which confirmed accuracy of the fiber in the lesion.This last o-arm scan showed the same jump in slices as the other two.Accuracy of the case was confirmed, no patient impact, error occurred after patient was under anesthesia and after first incision.Delay to case about 30 mins.Cr has noted that when viewing any of the scans directly from the o-arm, no jump between slices is observed.Only the scans that are part of the patient folder demonstrate this jump, causing the cr to believe that the rosa software was removing these slices.

Event Description

Company representative (cr) was present for a biopsy and ablation case.The surgeon positioned the patient prone using a regular mayfield and attached to the rosa.The surgeon then placed fiducials and got an o-arm spin (first generation) of the fiducials for registration.When cr went to load the scan into the rosa using a usb, the merge screen showed that some of the slices had been cut out, so that there was a strange jump in bone at the top of the head.When loading in the scan, the cr had received an error that there were gaps between slices.Cr thought that the scan had not copied correctly onto the usb, and so pulled the same exam from pacs.Cr confirmed that 191 slices were present in the exam in the iqview temporary folder.However, the same problem occurred on the merge screen, but the cr did not receive any errors this time from the rosa software.The surgeon noted that the patient had hardware from a shunt located at the same level where the slices seemed to jump.The surgeon decided to get another scan and tilt the gantry of the o-arm slightly to allow for clear visualization of the fiducials below the problem area.The 2nd scan was transferred by usb to the robot and gave the same error that there were gaps between slices.It also showed the same jump between slices as the first scan.The surgeon decided to try to proceed with registration because he felt that the merge below the problem area was accurate and included all of the fiducials.Registration was performed without issue and an rms of 0.62 was achieved.After verification, the surgeon felt comfortable to proceed with the biopsy and laser fiber placement.Before detaching from the rosa, the surgeon got another o-arm scan with the laser fiber in place, which confirmed accuracy of the fiber in the lesion.This last o-arm scan showed the same jump in slices as the other two.Accuracy of the case was confirmed, no patient impact, error occurred after patient was under anesthesia and after first incision.Delay to case about 30 mins.Cr has noted that when viewing any of the scans directly from the o-arm, no jump between slices is observed.Only the scans that are part of the patient folder demonstrate this jump, causing the cr to believe that the rosa software was removing these slices.

Manufacturer Narrative

A detailed analysis of the data logs has been performed.This analysis did not reveal any malfunction of the rosa device that would explain the reported issue with the exam display.Tests performed at the manufacturing site permitted to reproduce the issue with the dicom images taken from the patient folder, but not with the original dicom exams.Therefore a corruption of the data retrieved from the pacs could explain the reported issue.The accuracy of the electrode placement was not impacted by the issue.

• 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: 11250365
• MDR Text Key: 229301156
• Report Number: 3009185973-2021-00028
• 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: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• 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: ROSAS00203
• Device Lot Number: 3.1.4.1650
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1