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 12/22/2020

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 clinical representative (cr) assisted the surgeon with their ablation/biopsy case on (b)(6) 2020.Around 9:39am eastern time, the cr was attempting to load in post-op imaging through pacs to check accuracy, but there was a warning that an interpolation needed to be made since there was a gap in the imaging.After loading and trying to merge, it was clear that some of the slices didn't make it, and that was causing the issue.There was supposed to be 240 slices, but there was only 228.The imaging was sent through pacs again, and the cr noticed that this time all 240 slices were there.The imaging was loaded in and there was no error message this time.But, when looking at the merge, it appeared that those slices were still missing, even though they all appeared to be there.This merge (named exam 1) was accepted even though it was off, and loaded into the plan.The cr then tried to upload the same scan, doing every step the same, but named the imaging "exam 2".When looking at this loaded in and merged, it appeared to work just fine, and the merge was accepted.The cr continued to investigate this, and found out some issues.The cr deleted "exam 1" and continued to try and see what was causing the issue.The cr found that the imaging kept having the issue if it was named "exam 1".The cr only chose about 100 slices in the middle of the scan to be merged to the ct, but even though only some slices were chosen, the software still grabbed all 240 slices.No matter what amount of slices were chosen, it kept giving the same issue, and this was found to be because the name was "exam 1".When the cr changed the name to "exam" or another name, it appeared to fix both issues, which were all 240 slices would show, and then if only certain slices were selected for merging, it appeared only those were actually used in the merge.There seems to be an issue when the patient imaging being loaded in has the same name (exam 1 in this case) as a previously loaded exam.The initial issue where all slices didn't load in from pacs caused all the issues when naming it "exam 1", and then all attempts after that with the same name were not going to work.But naming it "exam 2" or another unique named seemed to clear any issues from before and start over new.The patient was under anesthesia and incision was made.The scan was a post-op scan to check for placement accuracy.Total delay was around 15 minutes.

Event Description

The clinical representative (cr) assisted the surgeon with their ablation/biopsy case on (b)(6) 2020.Around 9:39am eastern time, the cr was attempting to load in post-op imaging through pacs to check accuracy, but there was a warning that an interpolation needed to be made since there was a gap in the imaging.After loading and trying to merge, it was clear that some of the slices didn't make it, and that was causing the issue.There was supposed to be 240 slices, but there was only 228.The imaging was sent through pacs again, and the cr noticed that this time all 240 slices were there.The imaging was loaded in and there was no error message this time.But, when looking at the merge, it appeared that those slices were still missing, even though they all appeared to be there.This merge (named exam 1) was accepted even though it was off, and loaded into the plan.The cr then tried to upload the same scan, doing every step the same, but named the imaging 'exam 2'.When looking at this loaded in and merged, it appeared to work just fine, and the merge was accepted.The cr continued to investigate this, and found out some issues.The cr deleted 'exam 1' and continued to try and see what was causing the issue.The cr found that the imaging kept having the issue if it was named "exam 1".The cr only chose about 100 slices in the middle of the scan to be merged to the ct, but even though only some slices were chosen, the software still grabbed all 240 slices.No matter what amount of slices were chosen, it kept giving the same issue, and this was found to be because the name was 'exam 1'.When the cr changed the name to 'exam' or another name, it appeared to fix both issues, which were all 240 slices would show, and then if only certain slices were selected for merging, it appeared only those were actually used in the merge.There seems to be an issue when the patient imaging being loaded in has the same name (exam 1 in this case) as a previously loaded exam.The initial issue where all slices didn't load in from pacs caused all the issues when naming it 'exam 1', and then all attempts after that with the same name were not going to work.But naming it 'exam 2' or another unique named seemed to clear any issues from before and start over new.The patient was under anesthesia and incision was made.The scan was a post-op scan to check for placement accuracy.Total delay was around 15 minutes.

Manufacturer Narrative

A full analysis of the data logs has been performed and concluded that the first time the mri post-operative was loaded from the pacs, it was already truncated and the software detected that it was not conform to the acquisition protocol.The incorrect display of the exam is then a normal behavior.The cause for the truncation might be due to the copy from hospital server.Tests showed that it was not due to the software.When the loading of the exam with the correct number of slices was reattempted from pacs, the copy and display of the correct images was not possible.This can be explained by the fact that the previous truncated exam was recorded in the patient folder with the same name and identification number although it was not validated by the user.It is a known software anomaly that will be addressed through our design issues management process.

• 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: 11162185
• MDR Text Key: 232587409
• Report Number: 3009185973-2021-00004
• 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: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• 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: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1