MAUDE Adverse Event Report: MEDTECH SA ROSA BRAIN; COMPUTER-ASSISTED SURGICAL DEVICE

Model Number ROSA BRAIN 3.0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage, Cerebral (1889)

Event Date 08/13/2019

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).The device has not been evaluated yet for investigation purpose.Once the evaluation is performed, a follow-up medwatch report will be submitted.

Event Description

The surgeon was a 10 trajectories seeg case.The patient was anesthetized, pinned, and registered with bone fiducials.Verification was completed and registration was validated.The first 5 trajectories were implanted.On the 5h trajectory, the surgeon had some trouble puncturing the dura, but was able to get it placed.The surgeon then moved onto the next trajectory (trajectory1) and drilled the 2.45mm drill hole.There was blood coming back as soon as the drill was removed, so the surgeon flushed it with saline for a few minutes.Once the bleeding slowed, the surgeon decided to not implant that trajectory and moved onto the next (trajectory 2).This one was drilled and the same thing happened, when the bone was drilled, blood automatically came back.At this point, the patient was taken out of pins and transferred to a ct.The scan showed that there was an epidural hematoma.Rosa was removed from the room and the patient was brought back to the operating room, all of the electrodes that had been placed were all removed.A bone flap was then removed and the hematoma was evacuated.The ct scan was loaded into rosa and it was confirmed that all of the bolts were on trajectory, so the surgeon believes that it was the dura that they had trouble getting through on the 5th trajectory that caused the problem.The last pm on this robot passed without any problems.

Event Description

The surgeon had a (b)(4) trajectories seeg case.The patient was anesthetized, pinned, and registered with bone fiducials.Verification was completed and registration was validated.The first (b)(4) trajectories were implanted.On the 5h trajectory, the surgeon had some trouble puncturing the dura, but was able to get it placed.The surgeon then moved onto the next trajectory (trajectory1) and drilled the 2.45mm drill hole.There was blood coming back as soon as the drill was removed, so the surgeon flushed it with saline for a few minutes.Once the bleeding slowed, the surgeon decided to not implant that trajectory and moved onto the next (trajectory (b)(4) ).This one was drilled and the same thing happened, when the bone was drilled, blood automatically came back.At this point, the patient was taken out of pins and transferred to a ct.The scan showed that there was an epidural hematoma.Rosa was removed from the room and the patient was brought back to the or, all of the electrodes that had been placed were all removed.A bone flap was then removed and the hematoma was evacuated.The ct scan was loaded into rosa and it was confirmed that all of the bolts were on trajectory, so the surgeon believes that it was the dura that they had trouble getting through on the 5th trajectory that caused the problem.The last pm on this robot passed without any problems.

Manufacturer Narrative

Corrected data: b4 date of this report, d10 device availability, g4 date received by manufacturer, h2 if follow-up, what type, h3 device evaluated by manufacturer, h6 event problem and evaluation codes, and h10 additional narratives/data.A full analysis of the data logs has been performed, this analysis concluded that the registration was properly performed but the accuracy could have been improved by readjusting the 3d segmentation as recommended in the user manual.No particular issue was found in the set of exams and in their fusion.The analysis shows that the last electrode, on trajectory 6, was implanted 2.06 mm away from the planned trajectory entry point, which is slightly over the specification limit of 2 mm.The origin of this slight shift remains unknown.According to the complaint description, the surgeon suspected that the difficult puncturing of the dura on this trajectory might have caused the epidural hematoma.Although this could not be confirmed through our analysis, this remains a possible root cause.The analysis also shows that all the implanted electrodes were slightly curved inside the brain.This could result from various factors, such as the electrodes material, their stiffness, the patient anatomy and/or the method of implantation.None of them could be confirmed.This curvature of the electrodes might also be responsible for the reported bleeding, however this could not be confirmed.The surgeon was trained the(b)(6)2018 on the device and had already performed 10 assisted surgeries when the event occurred.The surgery was assisted.A complete maintenance was performed and passed on(b)(6)2019.No issue is suspected with the device.Analysis confirmed that the robot worked as expected and as intended.

• Brand Name: ROSA BRAIN
• 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: 9005610
• MDR Text Key: 161999283
• Report Number: 3009185973-2019-00318
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K172444
• 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: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ROSA BRAIN 3.0
• Device Catalogue Number: ROSA BRAIN
• Device Lot Number: 3.0.0.21
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/13/2019
• Initial Date FDA Received: 09/12/2019
• Supplement Dates Manufacturer Received: 04/02/2020
• Supplement Dates FDA Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other