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

Model Number ROSA ONE

Device Problem Malposition of Device (2616)

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

Event Date 02/28/2022

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

It was reported that the surgeon performed the fusion of the patient folder: 11 electrodes left and 3 electrodes right.Despite the neutral position of the robot, the arm was quite stretched on the left side and - on the contrary - rather 'physiologically' bent on the right side.So the fusion showed that on the left at the entry point, there is for all the electrodes an inaccuracy of 2 to 2.5 mm and this inaccuracy increases at the target point up to 3.5mm for some electrodes, which is not really satisfying for us.In contrast, on the right, the difference between ct electrodes and mri trajectories was much smaller for all 3.

Manufacturer Narrative

A full analysis of the data logs has been performed and this analysis concluded that the implantation of electrodes was determined accurate at the entry points and is at the very limit of specification of 2mm for the left side trajectories.The deviation at entry point is similar for all left trajectories.The deviation at target point follows the deviation of entry point in most cases as expected.However, three electrodes were identified slightly curved inside the brain which caused an inacceptable discrepancy at the target.However, the curvature of the electrode inside the brain and its depth depends on various factors, including - but not limited to - the material of the electrode, its stiffness, the patient anatomy and/or the method of implantation.None of these hypotheses can be confirmed to explain the deviations observed.A test at manufacturing site did not permit to confirm the user assumption of a link between the arm positioning (extended or not) and the accuracy on trajectories.The maintenance permitted to verify that the device was accurate during surgery.No robotic error was found though investigation and the cause for the shifts remains unknown.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.

Event Description

It was reported that the surgeon performed the fusion of the patient folder: 11 electrodes left and 3 electrodes right.Despite the neutral position of the robot, the arm was quite stretched on the left side and - on the contrary - rather 'physiologically' bent on the right side.So the fusion showed that on the left at the entry point, there is for all the electrodes an inaccuracy of 2 to 2.5 mm and this inaccuracy increases at the target point up to 3.5mm for some electrodes, which is not really satisfying for us.In contrast, on the right, the difference between ct electrodes and mri trajectories was much smaller for all 3.

• Brand Name: ROSA ONE
• Type of Device: COMPUTER-ASSISTED SURGICAL DEVICE
• Manufacturer (Section D): MEDTECH SAS; 432 rue du rajol; mauguio, languedoc-roussillon 34130 ; FR 34130
• Manufacturer (Section G): MEDTECH SAS; 432 rue du rajol; mauguio, languedoc-roussillon 34130 ; FR 34130
• Manufacturer Contact: jay sharma ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 13755490
• MDR Text Key: 288030714
• Report Number: 3009185973-2022-00023
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K200511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA ONE
• Device Catalogue Number: ROSAS00201
• Device Lot Number: 3.1.5.28
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2021
• 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