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

Model Number ROSA BRAIN 3.0

Device Problem Misconnection (1399)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2017

Event Type  malfunction  

Manufacturer Narrative

The device (b)(4) has not been evaluated yet for investigation purpose.Once the evaluation will be performed, a follow-up medwatch report will be submitted.

Event Description

It was reported that during a surgery while the surgeon attempted to start the device, the connection screen lasted for more than one minute.An error message was displayed on the screen and the device powered down.The field service engineer shutdown the robot stand, and unplugged it.The device was powered off for a full minute before attempting to reconnect.Once restarted no more issue was observed and the case was successfully completed.Post-operatively, the field service engineer was checking the device controller status and the same communication failure occurred.

Manufacturer Narrative

Following the investigation performed by reviewing the data log files from the subject event, on this occasion the root cause for the reported device shutdown cannot be determined.

• 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
• Manufacturer (Section G): MEDTECH SA; zac eureka; 900 rue du mas de verchant; montpellier, languedoc-roussillon 34000 ; FR 34000
• Manufacturer Contact: jay sharma ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 7036301
• MDR Text Key: 93036199
• Report Number: 3009185973-2017-00802
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK151359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: N/A
• Device Lot Number: 3.0.0.20
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2017
• Initial Date FDA Received: 11/16/2017
• Supplement Dates Manufacturer Received: 04/06/2018
• Supplement Dates FDA Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1