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

Model Number ROSA ONE

Device Problem Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2020

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

After finishing a seeg case, a post-op scan was taken in the operating room (while the patient was still under anesthesia) utilizing an o-arm.The scan was then transferred to the robot via usb and subsequently merged to a pre-op ct scan, which was the scan utilized for registration.The surgeon verified the merge and then compared the scan to the plan.The surgeon noted that the entry points on the post-op scan seemed deviated from the plan on each trajectory, however targets were all accurate.The surgeon did not express need for a revision.

Event Description

After finishing a seeg case, a post-op scan was taken in the operating room (while the patient was still under anesthesia) utilizing an o-arm.The scan was then transferred to the robot via usb and subsequently merged to a pre-op ct scan, which was the scan utilized for registration.The surgeon verified the merge and then compared the scan to the plan.The surgeon noted that the entry points on the post-op scan seemed deviated from the plan on each trajectory, however targets were all accurate.The surgeon did not express need for a revision.

Manufacturer Narrative

A full analysis of the data logs and of the patient folder has been performed.This analysis confirmed that the placement of the 12 implanted electrodes was inaccurate.No global trend has been identified.Therefore, it is not possible to conclude on the origin of the inaccuracy at the entry points.However, the surgeon reported that the target points were properly reached for this case.In the course of the investigation, it was also noted that the user did not recollect the point b with the robot arm after having adjusted its position on the image during the first and the third pre-registration performed.The ifus adequately recommend to recollect the points when they have been adjusted on the image.Corrected data: b4 date of this report.G4 date received by manufacturer.H2 if follow-up, what type.H3 device evaluated by manufacturer.H6 event problem and evaluation codes.H10 additional narratives/data.

• 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
• MDR Report Key: 10312486
• MDR Text Key: 200041304
• Report Number: 3009185973-2020-00161
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K182417
• 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: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• 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: ROSAS00203
• Device Lot Number: 3.1.1.1295
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1