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

Model Number ROSA ONE

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 03/07/2019

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.(b)(4).

Event Description

It was reported that an incorrect speed was displayed during robot arm clearance.The reporter stated that the robot arm speed was still slow even though he clicked on "free and fast".He reportedly clicked on slow, and fast again, and then the screen was displaying both "fast" and "slow" buttons pressed at the same time, while the robot was still in slow speed.This issue happened during a scheduled maintenance test.

Manufacturer Narrative

It was reported that there was an abnormal behavior.The robot arm speed was slow even when 'free and fast' was selected, and then the screen was displaying both 'fast' and 'slow' buttons pressed at the same time, while the robot was still in slow speed.Device history record review and complaint history review were not performed based on the low severity of this complaint.During the technical investigation nothing abnormal was found.Furthermore, issues described above were tried to be reproduced on manufacturing site, without success.Therefore, issues cannot be confirmed and their root cause cannot be determined.

Event Description

It was reported that an incorrect speed was displayed during robot arm clearance.The reporter stated that the robot arm speed was still slow even though he clicked on 'free and fast'.He reportedly clicked on slow, and fast again, and then the screen was displaying both 'fast' and 'slow' buttons pressed at the same time, while the robot was still in slow speed.This issue happened during a scheduled maintenance test.

• 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: 8477132
• MDR Text Key: 140900801
• Report Number: 3009185973-2019-00111
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ROSA ONE
• Device Catalogue Number: N/A
• Device Lot Number: 3.1.0.1276
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1