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

Model Number ROSA ONE

Device Problems Unintended Collision (1429); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been evaluated yet for investigation purpose.Once the evaluation is performed, a follow-up medwatch report will be submitted.

Event Description

While clearing the robot arm away from the patient from trajectory 8, the robot experienced a communication failure.The bolt had been placed and the surgeon was pulling the robot arm away from the patient in axial slow mode when he felt pressure against the direction he was trying to go in.He asked to be switched into fast mode, while i tried to switch to fast mode the rosa screen froze and robot arm moved in fast toward to patient¿s head and hit the patient.The instrument holder had the 2.45 drill adapter fixed in it.The rosanna program them stopped responding and the screen showed a windows error message 'program not responding' then switched back to the rosanna software and showed 'communication failure ¿ shutdown'.The surgeon took the adapter out of the instrument holder and the field service engineer rebooted the robot.Once rebooted the robot worked as it normally does.The surgeon would like a response back as to what may have caused this issue.His contact information is provided below.All log information is on the server.

Manufacturer Narrative

A full analysis of the data logs has been performed and led to the following observations : the reported event was confirmed : a communication error occurred when the surgeon applied a force on axis 5 of the robot arm.A timeout of the robot arm was detected and caused the shutdown of the device.However, the analysis did not permit to confirm whether it was the cause for the arm drift or only the consequence of the force applied to the arm.It is assumed that the arm was probably still running with the cooperative mode when the controller started to shutdown.Tests performed at the manufacturing site did not permit to reproduce the entire workflow described in the event description.Nevertheless, these tests revealed that the reported arm drift might have been caused by an incorrect calibration situation that might have occurred during the last tool calibration, such as : empty calibration followed by the instrument installation; touching the tool during calibration; calibration performed with the tool incorrectly mounted.None of these hypotheses could be confirmed.Analysis of available information was not conclusive, and the root cause for the issue remains unknown.This issue triggered a momentary software freeze whose cause cannot be confirmed.The software finally shutdown correctly, and the procedure could be successfully resumed.Corrected data: b4 date of this report.D4 additional device information.G4 date received by manufacturer.H2 if follow-up, what type.H3 device evaluated by manufacturer.H6 event problem and evaluation codes.

Event Description

While clearing the robot arm away from the patient from trajectory 8, the robot experienced a communication failure.The bolt had been placed and the surgeon was pulling the robot arm away from the patient in axial slow mode when he felt pressure against the direction he was trying to go in.He asked to be switched into fast mode, while i tried to switch to fast mode the rosa screen froze and robot arm moved in fast toward to patient¿s head and hit the patient.The instrument holder had the 2.45 drill adapter fixed in it.The rosanna program them stopped responding and the screen showed a windows error message 'program not responding' then switched back to the rosanna software and showed 'communication failure.Shutdown'.The surgeon took the adapter out of the instrument holder and the field service engineer rebooted the robot.Once rebooted the robot worked as it normally does.The surgeon would like a response back as to what may have caused this issue.His contact information is provided below.All log information is on the server.

• 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: 9529488
• MDR Text Key: 198740552
• Report Number: 3009185973-2019-00457
• 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: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• 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: 3.1.0.1276
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1