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

Model Number ROSAP00045

Device Problem Defective Component (2292)

Patient Problem No Code Available (3191)

Event Date 01/16/2019

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.(b)(4).

Event Description

On (b)(6) 2019 at approximately 10:55am, surgeon received error message impossible to record the point.Check that the distance to the tool is correct, then register the point again while trying to collect the first point (i.E.Top of the forehead) during contactless registration.Surgeon moved distance sensor ((b)(4)) closer to and further from the surface of the skin, but the same error occurred.Field service engineer (fse) restarted registration, but error continued to occur.Fse then unplugged distance sensor, and registration continued normally until manual scanning of the left side of the nose, when a new error message was seen: disconnection of the distance sensor was detected please restart the registration.Fse confirmed bad stability at the robot arm-laser connection, then fixed this connection with tape, and proceeded with registration.Patient was in the room and anesthetized, no incision was made, no clinical consequences, estimated time lost was 30 minutes.

Manufacturer Narrative

It was reported that the optical distance sensor (b)(6) lost connection during a seeg case.Dhr review and review of complaint history did not identify any contributory factors to the event.However, the device was returned with the offset plate (b)(6) at medtech montpellier for analysis.An automatic registration was performed at manufacturing side.The test was positive as the device is still functional for its intended purpose during the calibration, registration, verification and navigation steps.However, it was observed that the laser disconnected several times for micro seconds when the wire was moved and twisted the cable.The most probable cause of this malfunction is that the optical distance sensor connection was damaged.

Event Description

On (b)(6) 2019 at approximately 10:55am, surgeon received error message impossible to record the point.Check that the distance to the tool is correct, then register the point again while trying to collect the first point (i.E.Top of the forehead) during contactless registration.Surgeon moved distance sensor (b)(6) closer to and further from the surface of the skin, but the same error occurred.Field service engineer (fse) restarted registration, but error continued to occur.Fse then unplugged distance sensor, and registration continued normally until manual scanning of the left side of the nose, when a new error message was seen: disconnection of the distance sensor was detected please restart the registration.Fse confirmed bad stability at the robot arm-laser connection, then fixed this connection with tape, and proceeded with registration.Patient was in the room and anesthetized, no incision was made, no clinical consequences, estimated time lost was 30 minutes.

• 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: 8300740
• MDR Text Key: 134856251
• Report Number: 3009185973-2019-00024
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K151359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ROSAP00045
• Device Catalogue Number: DISTANCE SENSOR
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/16/2019
• Initial Date FDA Received: 02/04/2019
• Supplement Dates Manufacturer Received: 09/13/2019
• Supplement Dates FDA Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other