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

Model Number ROSA BRAIN

Device Problems Computer Software Problem (1112); No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the 3d model showing where the laser is in reference to the model appeared normally, but the three other views were completely black.Later on, when trying to select the mr imaging to be 'exam 2', an 'impossible to load the exam' message appeared, and then a windows shutdown was experienced.Device history record review and complaint history review were not performed based on the low severity of this complaint.The technical investigation indicated that the user loaded and displayed oversize exams, which is considered as a use error as the acquisition protocol ifu contains sufficient information.The display issue - views showing black - and the 'impossible to load the exam' events were due to an insufficient ram due to an unknown cause (oversized exam or computer configuration).The windows shutdown was due to a crash of the rosanna_brain application due to unknown cause (memory address was either misplaced or misread by the software).(b)(4).

Event Description

During a surgery, the verification of the registration was about to be performed, but an issue occurred on screen.The 3d model showing where the laser is in reference to the model appeared normally, but the three other views were completely black.There was not a view of anything in the three views, and the company field service engineer (fse) did everything they could to try and fix the issue (switched to different contrasts, switch to different imaging, etc.).The fse decided to skip through the verification, save and close the file, re-open the file, and try the verification again.The same result happened where the three views were completely black.When trying to select the mr imaging to be 'exam 2', an 'impossible to load the exam' message appeared, and then a windows shutdown was experienced.The robot was restarted and the verification was started again.This time the 3 views showed the ct imaging, and the verification was able to be performed.The patient was under anesthesia and no incisions were made.The total delay was less than 10 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
• 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: 9115616
• MDR Text Key: 205310423
• Report Number: 3009185973-2019-00327
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2019

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: N/A
• Device Lot Number: 3.0.0.21
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 09/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2018
• 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