Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Problem Image Display Error/Artifact (1304)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/17/2018
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.
 
Event Description
It was reported that before a surgery, the surgeon tried to perform the fusion between mri and ct, and wasn't able to do it as the ct was acquired with a tilt.The pre-op ct was not used to perform the surgery.
 
Manufacturer Narrative
It was reported that the surgeon could not obtain correct merge result between a mri and a ct.Event summary, device history record review and complaint history review did not identify contributing factors.Technical investigation confirmed that the orientation matrix of images was miscalculated by the software for the subject ct exam as it was acquired with a tilt.(b)(4).
 
Event Description
It was reported that before a surgery, the surgeon tried to perform the fusion between mri and ct, and wasn't able to do it as the ct was acquired with a tilt.The pre-op ct was not used to perform the surgery.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8072813
MDR Text Key127210689
Report Number3009185973-2018-00307
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
PMA/PMN Number
K151359
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberROSA BRAIN
Device Catalogue NumberN/A
Device Lot Number3.0.0.21
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
-
-