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 12/15/2020

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

During registration, surgeon finished lateral scan of right side of head, and arm started to move towards left side automatically.During this movement, there was no notification to surgeon other than temporary pause.Arm collided with surgeon's grip and caused a shutdown and restart event.This meant that registration was incomplete and needed to be restarted.Delay of surgery 20 minutes, ablation, no incision, patient under anesthesia for an additional 20 minutes.

Manufacturer Narrative

A collision was indeed detected during registration, in automatic movement.However, it did not provoke a shutdown since the automatic movement terminated successfully.A communication error occurred just after launching the cooperative mode due to the emergency button activation.The device responded as expected.As the emergency button was not enabled on purpose, it might be due to an isolated electrical event but it cannot be confirmed with the available data.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.

Event Description

During registration, surgeon finished lateral scan of right side of head, and arm started to move towards left side automatically.During this movement, there was no notification to surgeon other than temporary pause.Arm collided with surgeon's grip and caused a shutdown and restart event.This meant that registration was incomplete and needed to be restarted.Delay of surgery 20 minutes, ablation, no incision, patient under anesthesia for an additional 20 minutes.

• 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: 11155579
• MDR Text Key: 229167607
• Report Number: 3009185973-2021-00010
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K200511
• 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: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• 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: 3.1.4.1650
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1