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

Model Number ROSA BRAIN 3.0

Device Problem Unintended Collision (1429)

Patient Problem No Patient Involvement (2645)

Event Date 04/11/2016

Event Type  malfunction  

Manufacturer Narrative

The device br16006 has been inspected for investigation purpose.The analysis performed confirmed that the device was fully functional and was working as intented.The robot detected a collision on one of its axes and this led to a communication error.The internal complaint reference is the following: (b)(4).This report was submitted reported on (b)(6) 2017.As part our internal procedure the submission status was verified and appeared to be failed.For this reason this mdr is resubmitted.

Event Description

During a routine test as part of the preventive maintenance, it was identified that the rosa arm started to move through the registered phantom head and collided with the support arm.When trying to clear the collision, the rosa arm had a communication error due to the pressure from the collided distance sensor.In order to reset the arm, the distance sensor was unscrewed.There was no patient involvement reported.

• 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 ; zac eureka; 900 rue du mas de verchant; montpellier, languedoc-roussillon 34000 ; FR 34000 ; 467107740
• MDR Report Key: 6685501
• MDR Text Key: 79053355
• Report Number: 3009185973-2017-00428
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ROSA BRAIN 3.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1