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

Model Number ROSA BRAIN

Device Problems Failure to Power Up (1476); Electrical Power Problem (2925)

Patient Problem No Code Available (3191)

Event Date 04/08/2019

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

It was reported that when the field service engineer arrived the screen device was black and the power lights were not on.One of the nurses plugged in and turned on the robot the same morning before the fse arrived.The nurse said the robot never booted when he turned it on and that the screen was always blank that day.The surgery was delayed to the afternoon.The fse was able to determine that the issue was coming from the a fuse that was blown, and was able to replace it successfully.

Event Description

It was reported that when the field service engineer arrived the screen device was black and the power lights were not on.One of the nurses plugged in and turned on the robot the same morning before the fse arrived.The nurse said the robot never booted when he turned it on and that the screen was always blank that day.The surgery was delayed to the afternoon.The fse was able to determine that the issue was coming from the a fuse that was blown, and was able to replace it successfully.

Manufacturer Narrative

Device history record review and complaint history review did not identify contributing factors.It was reported that the device would not start up.Reportedly, on that day, the robot never booted on, the screen was always blank and the power lights were not on.On the event date, the company representative troubleshooted the issue.It was determined that the power issue was due to the q2 fuse that was blown.The q2 fuse is part of the power circuit.It was replaced by a new fuse on the same date.This replacement enabled the robot to turn on.The cause of the q2 fuse blown is unknown.A fuse is a safety component whose role is to open an electrical circuit in case of an electrical issue, typically in case of an overcurrent or short circuit.On this occasion the electrical issue cause that have led the q2 fuse to blew is unknown.However, this event is considered as a normal device behavior.Based on the investigation performed, there was no failure detected, the device operated within specification.Corrected data: b4 date of this report; d4 product information; 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.

• Brand Name: ROSA BRAIN
• 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: 8587031
• MDR Text Key: 144294062
• Report Number: 3009185973-2019-00162
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K172444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: ROSA BRAIN
• Device Catalogue Number: ROSAS00303
• Device Lot Number: 3.0.0.21
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1