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

Model Number ROSA BRAIN 3.0

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 03/04/2019

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.  udi# : ((b)(4).

Event Description

After seeg surgery on (b)(6) 2019, cst on site noticed that the deported pc button was not working and did not show the blue light to indicate that it was functioning.This was noticed after the surgery and had no effect on the patient.The surgery was unaffected.No logs were obtained as the issue appeared to be hardware related and not affected by the controller or rosanna/mario software.

Manufacturer Narrative

It was requested to check the state of deported pc button wire.After a check of the electrical wire connection by the field service engineer, he observed that the deported button wires were disconnected when he opened up the robot.The deported button worked again as the fse put wires back together.Device is now fully functional, no new event related to this issue has been reported since this event.

Event Description

After seeg surgery on (b)(6) 2019, the field service engineer on site noticed that the deported pc button was not working and did not show the blue light to indicate that it was functioning.This was noticed after the surgery and had no effect on the patient.The surgery was unaffected.

• 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: 8477007
• MDR Text Key: 140786208
• Report Number: 3009185973-2019-00114
• 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: 04/15/2020

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: Health Professional
• Device Model Number: ROSA BRAIN 3.0
• Device Catalogue Number: ROSA BRAIN
• Device Lot Number: 3.0.0.21
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1