MAUDE Adverse Event Report: MEDTECH SAS ROSA ONE SYSTEM - EU PLUG E; COMPUTER-ASSISTED SURGICAL DEVICE

Model Number ROSA ONE 3.1

Device Problems Malposition of Device (2616); Program or Algorithm Execution Failure (4036)

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

Event Date 04/25/2022

Event Type  malfunction  

Manufacturer Narrative

Dhr review and review of complaint history did not identify any contributory factors to the event.A full analysis of the data logs has been performed and concluded that an inaccuracy is confirmed for the ten electrodes, between 4.7 mm and 6.5 mm.This inaccuracy is due to a fusion error between the registration ct and the planning ct.The user should have verified the fusion and manually re-adjusted it before validation.Furthermore, the planning ct had a slice thickness of 3 mm, which is over the recommendations of the acquisition protocol, and can impact the quality of the automatic fusion.The robot was accurate in regard to the registration exam.The user altered the leksell frame by drilling markers in it, which is against the recommendations and can impact the reliability of the device.Udi# : (b)(4).

Event Description

The surgeon fixed the patient in the leksell frame and added some additional markers on the leksell frame.First attempt of registration, the markers were to loose, so he decided to put some wax.Then the markers were stable enough for him.Fusion between the airo image and the ct did not give a good result.They adjusted manually, tried several times with less slices, due to artefacts from the leksell frame holder.Finally he confirmed the fusion and set markers in the image.The regsitration error was not ideal with 0,96 mm, but still rated green.Verification was done.Accuracy on the airo image was ok.The surgeon sent the robot to the trajectory x put in a rod and took another ct with the airo.This time the fusion was confirmed quicker.All scews/anchors were implanted and then all electrodes were implanted at the end of the surgery.Post-operative ct showed an entry point error of 4 mm while the target point error was around 1 mm.The entry point error was found to be due to a rotational error in the fused airo ct, which was used for registration.

• Brand Name: ROSA ONE SYSTEM - EU PLUG E
• 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: 14467958
• MDR Text Key: 300358263
• Report Number: 3009185973-2022-00031
• 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
• Report Date: 05/20/2022

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: Health Professional
• Device Model Number: ROSA ONE 3.1
• 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
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2021
• 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