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

Model Number ROSA ONE

Device Problem Erratic or Intermittent Display (1182)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2020

Event Type  Injury  

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.Unique identifier (udi) #: (b)(4).

Event Description

The theater manager called the company representative to inform that during the surgery the monitor turns off when the robot was moving into trajectory.The issue occurred two times even after a reboot.They changed rosa for another surgery tool.

Manufacturer Narrative

A full analysis of the data logs has been performed.This analysis did not permit to confirm the occurrence of the event described on (b)(6) 2020.No logs were found on that date.The device passed the preventive maintenance that was performed on (b)(6) 2020.Corrected data: b4: date of this report.D4: lot number.G3: date received by manufacturer.H2: if follow-up, what type.H3: device evaluated by manufacturer.H6: adverse event problem.H10: additional narratives/data.

Event Description

The theater manager called the company representative to inform that during the surgery the monitor turns off when the robot was moving into trajectory.The issue occurred two times even after a reboot.They changed rosa for another surgery tool.

• 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: 11054631
• MDR Text Key: 224059425
• Report Number: 3009185973-2020-00327
• 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: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA ONE
• Device Catalogue Number: ROSAS00201
• Device Lot Number: 3.1.4.1650
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1