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 10/12/2020

Event Type  malfunction  

Manufacturer Narrative

A full analysis of the data logs has been performed.This analysis concluded that the first merge of the ct scan with the mri did not provide the same results as the second merge.The log files show that a manual adjustment (translation) was applied before validating the first merge.This merge was reportedly inaccurate.A second merge was then performed without any manual adjustments and was accurate, as reported.The root cause for the incorrect first merge cannot be determined, but it might result from an inadvertent translation applied by the user, although this hypothesis cannot be confirmed.No anomaly of the device was identified, the robot behaved as expected and as specified.Unique identifier (udi) #: (b)(4).

Event Description

The clinical representative (cr) was present for a rns case performed on (b)(6) 2020.The doctor was performing fiducial registration with the rosa robot.She was happy with the rms accuracy value and then proceeded to the verification stage.The doctor approached specific anatomical locations she wanted to evaluate instead of the recommended ones on the rosa screen.On the third location, she asked cr to pull up the mri too since they were evaluating just the ct images during verification.She wanted cr to have the image be showing an overlay that is half mri and half ct.Cr went to the exam manager menu and selected exam 1 as mri and exam 2 as ct.He then went onto the rosa merge display section.As he moves the slider back and forth, he noticed that the mri did not appear to be merged correctly with the ct image at approximately 11:49 am.Cr and the doctor did not know if a software glitch occurred to show this problem and that the actual merge is actually ok.They completed the verification stage before evaluating this merge issue.After verification, cr opened up the rosa merge display section again and saw that the mri and ct indeed did not seem to align correctly to each other.Cr and the doctor decided to delete the ct image series since the other two mri image series looked like it merged to each other well.They then re-upload the same ct images and merged it to the mri again.The doctor then went to the marker section and noticed within the 3d view that the previously placed marker points did not match up with the bone fiducials visible in the re-uploaded ct images.Cr asked the doctor if she previously checked the original ct to mri automatic merging process thoroughly.She said she did check.She deleted all the markers and redid the marker placement process.She proceeded to redo the registration and verification over again.She was happy with the new rms value, especially since it was lower than the first registration attempt.The doctor thought the verification checks were good as well.The verification stage ended approximately at 12:07 pm.Therefore, the total surgery delay time is roughly 18 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
• Manufacturer (Section G): MEDTECH SA; zac eureka; 900 rue du mas de verchant; montpellier, languedoc-roussillon 34000 ; FR 34000
• Manufacturer Contact: jay sharma ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 10792038
• MDR Text Key: 214799664
• Report Number: 3009185973-2020-00270
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 11/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1