• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTECH SA ROSA BRAIN COMPUTER-ASSISTED SURGICAL DEVICE Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameROSA BRAIN
Type of DeviceCOMPUTER-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 Key9115616
MDR Text Key205310423
Report Number3009185973-2019-00327
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172444
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received09/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROSA BRAIN
Device Catalogue NumberN/A
Device Lot Number3.0.0.21
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/26/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/10/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

-
-