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

Model Number N/A

Device Problem Unintended Collision (1429)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2017

Event Type  malfunction  

Manufacturer Narrative

The device br16018 has not been evaluated yet for investigation purpose.Once the evaluation will be performed, a follow-up medwatch report will be submitted.

Event Description

During surgery the device robot arm collided with the mayfield head frame.The collision was detected by the software and device did shutdown.Surgery was pursued after a device restart.

Manufacturer Narrative

Investigation into this event indicated that the reason for the collision is user related.User should have stopped the robot arm movement by releasing the vigilance device to avoid the collision.The ifu contains necessary instructions about the vigilance device usage, and the surgeon who was operating the device when the event occurred has been trained to the use of the rosa brain device.The device shutdown that followed the collision is a normal system behaviour: the shutdown is a safety measure, which immediately stops the device and limits the impact of the collision.Corrected data: date of this report.Date received by manufacturer.If follow-up, what type.Evaluation code.

• 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: 6544149
• MDR Text Key: 74426002
• Report Number: 3009185973-2017-00604
• 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: Medical Equipment Company Technician/Representative
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 11/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• 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