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

Model Number ROSA ONE 3.1

Device Problem Unintended Collision (1429)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A full analysis of the data logs has been performed, this analysis concluded that the issue is due to a user error and all elements permit to confirm that the device behaved as expected.A collision occurred during the automatic movement of the clearance procedure.The arm was not cleared in cooperative mode prior to the automatic release to the intermediary position.The arm passed from its last positon to the intermediary position without taking account of the environment.That is why the arm shot upwards while being over the bolt.In addition, regarding the ifu information, the collision could have been avoided by releasing the pedal.The collision provoked the timeout of the controller and the device shutdown.

Event Description

The field service engineer (fse) was at cook children¿s for an seeg case on (b)(6) 2020.Although this site is not independent of our services yet, they have a super user that controls the robot during the cases.The fse role is just providing supervision.During the case, the fse stepped out to grab a laptop from another surgeon, and was called back due to a collision.While the surgeon was on the track for a trajectory, in axial slow, they had the instrument adapter over a bolt that was already placed.While attempting to pull the arm back, the arm shot upwards, lodging the bolt into the instrument adapter and causing the arm to move towards the head.The collision occurred when the adapter was pressed up against the head.In order to clear, they were able to remove the instrument adapter, and then restart the robot and successfully clear the arm.This caused about a 15 min delay to the case.The biggest concern for the surgeon was why the arm shot upwards while being over the bolt.

• 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: 9691696
• MDR Text Key: 200844380
• Report Number: 3009185973-2020-00041
• 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
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• 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: ROSA ONE
• 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
• Date Manufacturer Received: 01/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2018
• 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 Sequence Number: 1