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

Model Number ROSA ONE

Device Problem Unintended Collision (1429)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2020

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.(b)(4).

Event Description

While driving in axial slow toward the patient on trajectory, joint 5 hit the head frame of the patient.This caused the robot to shutdown.There was no harm or movement of the patient.The company field service engineer changed the orientation of the arm so that the arm could approach the patient with a clear trajectory.After restarting the robot, the surgery continued with less than a 5 minute delay.

Event Description

While driving in axial slow toward the patient on trajectory, joint 5 hit the head frame of the patient.This caused the robot to shutdown.There was no harm or movement of the patient.The company field service engineer changed the orientation of the arm so that the arm could approach the patient with a clear trajectory.After restarting the robot, the surgery continued with less than a 5 minute delay.

Manufacturer Narrative

Device history record review and complaint history review were not performed based on the low severity of this complaint.An analysis of the data logs from the subject event has been performed.This analysis concluded that the collision between the arm of the robot and the patient¿s head frame caused the error with the controller and the shutdown of the device.It is a normal behavior of the device.The release of the vigilance device could have avoided the collision, as indicated in the user manual.The surgery was resumed properly after the reboot.Based on the investigation performed, the technical root cause of the event was determined to be an unintended use error.Corrected data: b4 date of this report.G4 date received by manufacturer.H2 if follow-up, what type.H3 device evaluated by manufacturer.H6 event problem and evaluation codes.

• 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: 9710595
• MDR Text Key: 198535945
• Report Number: 3009185973-2020-00048
• 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: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 3.1.1.1295
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 02/14/2020
• Supplement Dates Manufacturer Received: 03/19/2020
• Supplement Dates FDA Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1