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

Model Number ROSA ONE

Device Problems Image Display Error/Artifact (1304); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2020

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

Company clinical representative (cr) was assisting for two ablation cases. During the first case, although the fiducial registration looked accurate, the surgeon mentioned that the trajectory placement seemed to be almost a centimeter displaced inferiorly. Upon investigation of the patient folder, there were certain parts of the scan where the merge did not seem to line up. To summarize, the patients left side as well as the structures within the brain seemed to lineup very well. However, the right side of the skin surface was completely off. It appeared as if there was some distortion on the right side of the mr causing this issue. Since the lead placement was on the right side of the head, this lined up with the complaint from the surgeon. This was the first case since the robot was upgraded, causing concern with the surgeons on using the robot.

• 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: 10604939
• MDR Text Key: 209154398
• Report Number: 3009185973-2020-00238
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200511
• 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: 10/23/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: ROSA ONE
• Device Catalogue Number: ROSAS00203
• Device Lot Number: 3.1.4.1650
• 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: 11/16/2018
• 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