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

Model Number OPTICAL DISTANCE SENSOR

Device Problem Calibration Problem (2890)

Patient Problem No Patient Involvement (2645)

Event Date 06/17/2020

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.Unique identifier (udi) #: unknown.

Event Description

During a preventive maintenance (pm), the company field service engineer (fse) was performing the brain accuracy check of the optical distance sensor/laser and the laser failed the test multiple times.The wired connection was checked to see if it was being pinched and loosened during the test, but it was not.Multiple, different error messages were shown.A few restarts occurred and the tests still failed.A registration was attempted a few times with a phantom head, but error messages/shutdowns occurred.The rest of the testing for the pm was tested and passed.The optical distance sensor was the only equipment/tool that failed.

Manufacturer Narrative

A full analysis of the data logs has been performed.This analysis concluded that the distance sensor had failed the accuracy check because it was temporarily disconnected.Unplugging the usb cable of the distance sensor from the computer and plugging it back in fixed the problem.Based on the investigation performed, the technical root cause of the event was determined to be a wiring issue (usb cable incorrectly plugged in).Corrected data: - b4 date of this report; - d5 operator of device; - g4 date received by manufacturer; - h2 if follow-up, what type; - h3 device evaluated by manufacturer; - h6 event problem and evaluation codes; - h10 additional narratives/data.

Event Description

During a preventive maintenance (pm), the company field service engineer (fse) was performing the brain accuracy check of the optical distance sensor/laser and the laser failed the test multiple times.The wired connection was checked to see if it was being pinched and loosened during the test, but it was not.Multiple, different error messages were shown.A few restarts occurred and the tests still failed.A registration was attempted a few times with a phantom head, but error messages/shutdowns occurred.The rest of the testing for the pm was tested and passed.The optical distance sensor was the only equipment/tool that failed.

• 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: 10222835
• MDR Text Key: 202024542
• Report Number: 3009185973-2020-00154
• 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: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1