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

Model Number ROSA ONE 3.1

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi) #: (b)(4).A full analysis of the data logs and the patient folder has been performed and this analysis concluded that the placement of all the electrodes implanted is inaccurate.The 11 implanted electrodes are homogeneously translated in the superior direction and slightly in the anterior one.The result of the registration and the verification confirmed that the registration was correctly performed and accurate.Therefore, the main hypothesis is that the patient's head moved downwards between the verification and the start of surgery.However, no head motions were reported by the user, therefore this hypothesis cannot be confirmed.The analysis of the logfiles also revealed that during the coarse registration, some points have not been recollected with the robot arm although their position had been adjusted on the image.Please note that the instructions for use recommend that during the coarse registration, if you need to adjust the position of an initial point on the image, you have to recollect the same point with the robot arm.

Event Description

Post-operative mri revealed deviation of electrode placement for seeg procedure.Electrode placement deviated 3-5mm from planned location.The patient was not harmed due to this deviation and a revision procedure is not expected.Contactless registration revealed a significant error message however, registration verification revealed error of approximately 1.2mm which was agreed to be sufficient.

• 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: 12251198
• MDR Text Key: 264516093
• Report Number: 3009185973-2021-00173
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K200511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• 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: ROSAS00216
• Device Lot Number: 3.1.4.1650
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2019
• 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