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

Model Number ROSA BRAIN

Device Problem Unintended Collision (1429)

Patient Problem Bruise/Contusion (1754)

Event Date 11/27/2018

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.Unique identifier (udi) #: (b)(4).

Event Description

It was reported that there was a collision between the robot arm with the pointer probe attached and the patient's head during the registration.The reported stated that he had to hit the emergency stop button to stop the robot arm movement.

Manufacturer Narrative

Corrected data: - b4 date of this report - d4 catalog number - g4 date received by manufacturer - h2 if follow-up, what type - h3 device evaluated by manufacturer - h6 event problem and evaluation codes - h10 additional narratives/data it was reported that a collision occurred when the pointer probe was attached to the robot arm.It is stated that the robot arm was pushing the patient¿s forehead and that a bruise appeared on patient¿s head after this event.It is not sure that the foot pedal was pressed, however, according to the surgeon, even when he lifted his foot off the pedal he could still hear and see the robot pushing in, and he had to hit the emergency stop button in order to stop the arm from moving.Event summary, device history record review and complaint history review did not identify contributing factors.The investigation indicates that a drift of the robot arm can be observed when the foot pedal is pressed and if: - the tool is damaged, - the empty or/and tool calibration is/are incorrectly performed - the force sensor has an issue.The available data do not allow to confirm the issue, therefore the root cause for the issue cannot be determined.A complete maintenance was performed the day after the surgery ((b)(6) 2018) and the pointer probe was found to be conforming.

Event Description

It was reported that there was a collision between the robot arm with the pointer probe attached and the patient's head during the registration.The reported stated that he had to hit the emergency stop button to stop the robot arm movement.

• 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: 8189791
• MDR Text Key: 131175825
• Report Number: 3009185973-2018-00358
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

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
• Device Catalogue Number: ROSAS00303
• Device Lot Number: 3.0.0.21
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 03/16/2020
• Supplement Dates FDA Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1