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

Model Number ROSA ONE 3.1

Device Problems Computer Software Problem (1112); Unintended Collision (1429)

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

Event Date 10/04/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation of this event is in progress to determine the root cause of the event.Once the evaluation is completed, a follow-up medwatch report will be submitted.Unique identifier (udi) #:(b)(4).The investigation is on-going.

Event Description

During a procedure to place 13 electrodes for a seeg, the following events occurred: upon turning on the rosa robot, the emergency stop button was on when not pressed.The robot had to be turned off, unplugged and plugged back in.When the initial reference points were registered, it was not possible to correct them according to the usual procedure.The recalibration had to be redone and then, during the second attempt, a manual correction of the "blue points" by superimposing them on the "red ones" was performed.The robot then asked to revalidate all the points.During the laser scanning (wings of the nose and temples of the patient), the scanning of the left temple never ended, it was necessary to cancel the scanning of this zone, no cause was found.The other areas could be scanned normally.During the accuracy check, the mandatory points of the check procedure could be validated but only one additional check point could be validated.An error message was displayed after checking this point "the robot is in a singular position.The cooperative mode will be restarted in slow speed".The accuracy of the recalibration was correct.It was therefore decided to continue the procedure.The first 9 electrodes were positioned according to the procedure.During the implantation of the tenth electrode, no one was pressing the pedal and the mobility was set to "axial".The arm made a movement that was not at all in line with the trajectory.A piece of the coagulation electrode broke off in the patient's skull.According to our information, there were no clinical consequences for the patient after the seeg electrode placement surgery.This electrode #10 was therefore not implanted.Then, the 3 last electrodes implanted were reportedly off by ~5mm.During the regularly planned seeg electrode removal surgery, the surgeon successfully removed the part of the coagulation electrode sheath that fractured and remained implanted, as reported by the clinical services team after an additional follow-up discussion with the surgeon.No adverse consequence for the patient was reported other than the additional scar resulting from the trepanation of the skull that was needed to proceed.

Manufacturer Narrative

The unexpected axial drift described in complaint was investigated by r&d.This investigation could not confirm the autonomous drift event described and confirmed that the inaccuracies were due to a head holder movement.Indeed, the detailed analysis of the different logs and data received show that the axial movement in cooperative mode remained on the same axis from the beginning to the end of the movement concerned for electrode n°10 (i.E.The electrode which was the subject of the incident) and did not show the inappropriate movement of the robot arm reported.However, the detailed study of the last 3 trajectories (electrodes n°11, 12 and 13) revealed a rotation of the patient's head around a specific axis, which would result in the incorrect placement of these electrodes.Following in depth 3d digital simulations of these electrodes, the most likely cause of the reported event could be a movement (rotation) of the patient's head during the surgery, during the placement of electrode n°10.This movement would have caused the deterioration of the sheath of electrode n°10, and the numerical simulations carried out show that the parameters of this rotation are coherent with the observed shift of the last 3 implanted electrodes.- analysis shows that for both starting errors, with the emergency button on, the controller did not initiate properly and required to be rebooted.The issue is known and according to our supplier, it is due to the version of the source code in the controller.- when correcting the initial points, the distance sensor was detected out of the measurement range.Therefore, the points could not be recorded, as expected, but the user does not have any visual indication about the distance sensor positioning issue.This issue will be addressed through the continuous improvement process of our products.- analysis confirms that the manual scanning was longer than expected and was interrupted four times by the user.The scanning of left temple was skipped and it did not impact the accuracy of registration.The cause for this error could not be confirmed by data.An occurrence analysis shows that the distance sensor behaved properly for all the other laser registration performed with this pc (21 cases).The distance sensor passed the maintenance test of 18-feb-2022.- the data of joints positioning as well as the picture of the arm in singular position confirms that the device behaved as expected on the last event reported since the singularity error triggered corresponded to the alignment of the arm axis.

Event Description

During a procedure to place 13 electrodes for a seeg, the following events occurred: -upon turning on the rosa robot, the emergency stop button was on when not pressed.The robot had to be turned off, unplugged and plugged back in.- when the initial reference points were registered, it was not possible to correct them according to the usual procedure.The recalibration had to be redone and then, during the second attempt, a manual correction of the "blue points" by superimposing them on the "red ones" was performed.The robot then asked to revalidate all the points.- during the laser scanning (wings of the nose and temples of the patient), the scanning of the left temple never ended, it was necessary to cancel the scanning of this zone, no cause was found.The other areas could be scanned normally.- during the accuracy check, the mandatory points of the check procedure could be validated but only one additional check point could be validated.An error message was displayed after checking this point "the robot is in a singular position.The cooperative mode will be restarted in slow speed".The accuracy of the recalibration was correct.It was therefore decided to continue the procedure.The first 9 electrodes were positioned according to the procedure.During the implantation of the tenth electrode, no one was pressing the pedal and the mobility was set to "axial".The arm made a movement that was not at all in line with the trajectory.A piece of the coagulation electrode broke off in the patient's skull.According to our information, there were no clinical consequences for the patient after the seeg electrode placement surgery.This electrode #10 was therefore not implanted.Then, the 3 last electrodes implanted were reportedly off by ~5mm.During the regularly planned seeg electrode removal surgery, the surgeon successfully removed the part of the coagulation electrode sheath that fractured and remained implanted, as reported by the clinical services team after an additional follow-up discussion with the surgeon.No adverse consequence for the patient was reported other than the additional scar resulting from the trepanation of the skull that was needed to proceed.

• Brand Name: ROSA ONE
• Type of Device: COMPUTER-ASSISTED SURGICAL DEVICE
• Manufacturer (Section D): MEDTECH SAS; 432 rue du rajol; 900 rue du mas de verchant; mauguio, languedoc-roussillon 34130 ; FR 34130
• Manufacturer (Section G): MEDTECH SAS; 432 rue du rajol; 900 rue du mas de verchant; mauguio, languedoc-roussillon 34130 ; FR 34130
• Manufacturer Contact: jay sharma ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 12745744
• MDR Text Key: 280008026
• Report Number: 3009185973-2021-00179
• 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: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• 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: 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: 03/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2016
• 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