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

Model Number ROSA ONE

Device Problem Unintended Movement (3026)

Patient Problem No Patient Involvement (2645)

Event Date 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

Udi#: (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

Field service engineers (fse) were present during a training at (b)(6) with robot (b)(4).When fses went to first drive the arm from parked position to home (predefined positions), the arm connected to the controller, but would not move when the pedal was pressed.Stepping off the pedal resulted in the normal message that the pedal had been released, so the software believed the arm was moving.Shutting down the robot and restarting fixed the issue.No patient involvement.

Event Description

Field service engineers (fse) were present during a training at springfield memorial with robot bs19037.When fses went to first drive the arm from parked position to home (predefined positions), the arm connected to the controller, but would not move when the pedal was pressed.Stepping off the pedal resulted in the normal message that the pedal had been released, so the software believed the arm was moving.Shutting down the robot and restarting fixed the issue.No patient involvement.

Manufacturer Narrative

Dhr review and review of complaint history were not performed based on the low severity of this complaint.According to the complaint description, during a surgeon¿s training, fses went to first drive the robot arm from parking to home position (predefined position), the robot arm would not move when the foot pedal was pressed.This issue was due to a misconnection of the starc card.The starc card was moved to a new free slot of the controller.The device passed the preventive maintenance following the change of slot.

• 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: 9203359
• MDR Text Key: 166599016
• Report Number: 3009185973-2019-00361
• 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
• Type of Report: Initial,Followup
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1