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

Model Number OPTICAL DISTANCE SENSOR

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2021

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

Event Description

While registering with the distance sensor attached, the distance sensor cable got caught in the arm joint.This gave an error saying the robot could not drive to trajectory.The software forced a restart and the cable was dislodged.The case resumed.The distance sensor is not damaged.

Manufacturer Narrative

A full analysis of the data logs has been performed and this analysis concluded that the distance sensor cable was pinched in joint during the automatic movement for the registration scanning step.It provoked an error in the controller and the procedure was stopped as expected.This issue that will be addressed through the continuous improvement process of our products.Corrected data: b4 date of this report, 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

While registering with the distance sensor attached, the distance sensor cable got caught in the arm joint.This gave an error saying the robot could not drive to trajectory.The software forced a restart and the cable was dislodged.The case resumed.The distance sensor is not damaged.

• 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: 12105828
• MDR Text Key: 263831263
• Report Number: 3009185973-2021-00160
• 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: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPTICAL DISTANCE SENSOR
• Device Catalogue Number: ROSAS00316
• Device Lot Number: ROSA3-277B
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1