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 06/18/2020

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 driving to trajectory "sup ins" in automatic mode the arm collided with a bolt.The robot proceeded to shut down and was restarted.The arm was cleared and the case resumed.There was a less than 5 minute delay with no patient impact.

Manufacturer Narrative

A full analysis of the data logs has been performed and concluded that the collision between the end effector of the robot arm and an anchor bolt created a force exceeding the force sensor threshold during an automatic movement.This resulted in the forced shutdown of the device, which is the normal behavior of the device in such case.The proper management of the vigilance device by the user could have stopped the move and avoided the collision, as indicated in the user manual.

Event Description

While driving to trajectory "sup ins" in automatic mode the arm collided with a bolt.The robot proceeded to shut down and was restarted.The arm was cleared and the case resumed.There was a less than 5 minute delay with no patient impact.

• 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: 10187954
• MDR Text Key: 196211716
• Report Number: 3009185973-2020-00153
• 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: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• 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
• Date Manufacturer Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1