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

Model Number ROSA 2.5.8

Device Problems Unintended Collision (1429); Device Displays Incorrect Message (2591)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 09/11/2017

Event Type  Injury  

Manufacturer Narrative

The device 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 an error message pop up and the robot refused to move.The surgeon had later to stop the automatic movement because the robot arm would have touched patient head.The surgeon modified the trajectory and no more issues were noticed.

Manufacturer Narrative

The device (b)(4) data log files from the subject surgery has been inspected for investigation purpose.Investigation confirmed that the device (b)(4) worked as intended, there was no device malfunction.Depending on the orientation and positioning of the trajectories planned by the user, the robot may have to make a movement through patient's head to reach the trajectory.This is a normal device behavior.In this case, the user has to modify the trajectory in order to enable the robot arm to reach the trajectory without passing through patient's head.In this specific case that is what the user did in order to reach the required trajectory, after the trajectory was modified the robot arm reached the desired trajectory.Note: the rosa surgical devices are equipped with a vigilance device for monitoring the robot arm movements.This operating principle applies to all steps of the device use.As soon as the user releases the vigilance device, the robot arm movement is interrupted.(b)(4).

• Brand Name: ROSA SURGICAL DEVICE
• 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: 6913615
• MDR Text Key: 88150616
• Report Number: 3009185973-2017-00723
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PK101791
• 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: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA 2.5.8
• 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?: Yes
• Date Manufacturer Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2015
• 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