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 Known Impact Or Consequence To Patient (2692)

Event Date 07/28/2020

Event Type  Injury  

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. (b)(4).

Event Description

The following event occurred during a dbs case on (b)(6) 2020: following the implantation of two leads, utilizing the fhc stardrive for a dbs case, a post-op scan was taken while the patient was still under anesthesia, although disconnected from the robot, using the bodytom. The scan was transferred and merged to the mri on the rosa robot in order to confirm placement of the leads. After checking that the merger was accurate, it was found that when looking at the planned trajectories, that the right lead was 8mm shallow than the planned target (the entry point of the right lead was completely accurate). There was also no accuracy issues with the left lead. At this point, the surgeon determined that the right lead would need to be advanced the 8 mm on the right side, which would ultimately require the lead to be removed and replaced. Surgeon and the residents that were present believed that the lead had been retracted slightly when the watch-face had been placed on top to secure the lead, thus that the error had not been due to the robot, but rather user error. The plan was not altered and the patient was then reconnected to the rosa robot again using the leksell headframe adaptor. Registration was again performed utilizing bone fiducials and the most recent bodytom post-op scan. The surgeon then drove the rosa robot back to the right side trajectory where they again opened the patient's incision. At this point, when examining the lead the surgeon was able to see the mark that they had made on the lead with a marking pen was in fact above the watch-face indicating it had been somehow pulled out slightly. The lead was safely removed and the rosa robot was driven to the right trajectory (utilizing again the proper 160mm instrument length required for the fhc stardrive). The right lead was then replaced utilizing the microdrive and the surgeon then drove the robot to the home position. Following the closure, another post-op scan utilizing the bodytom was used. Merging the post-op scan to the mri, it was found that the lead had been accurately placed and now the right and left leads were accurate/at the planned target. Due to the surgeon's request to replace the lead, the surgery continued an extra 1 hr 45 min from the first post-op scan to the final post op scan. The patient was under prolonged anesthesia.

• 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
• Manufacturer (Section G): MEDTECH SA; zac eureka; 900 rue du mas de verchant; montpellier, languedoc-roussillon 34000 ; FR 34000
• Manufacturer Contact: jay sharma ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 10367948
• MDR Text Key: 205311371
• Report Number: 3009185973-2020-00188
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: ROSA ONE
• Device Catalogue Number: ROSAS00203
• Device Lot Number: 3.1.1.1295
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 10/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2018
• 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 Treatment Data

Date Received: 08/05/2020 Patient Sequence Number: 1