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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTECH SA ROSA ONE; COMPUTER-ASSISTED SURGICAL DEVICE
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MEDTECH SA ROSA ONE; COMPUTER-ASSISTED SURGICAL DEVICE Back to Search Results
Model Number ROSA ONE
Device Problem Image Display Error/Artifact (1304)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Date 09/14/2020
Event Type  malfunction  
Manufacturer Narrative
Udi#: (b)(4).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
The surgeon brought up several issues with the new planning software on her laptop.On the robot, during the case we were attempting to look at the mr image for confirmation.When attempting to look at the mr, it was completely blank.The exam manager would say that the mr was selected on both the 3d and as one of the images, but the 3d rendering would never show up, and if you scrolled to the mr between the scans it would be blank.This image would show up on the planning station, but when transferred over, the mr would be blank yet still recognized on the robot.
 
Manufacturer Narrative
A full analysis of the patient folder has been performed.This analysis concluded that the reported display issue of the mri renamed 't1wgad' is due to a known software anomaly related to the contrast management of the mri.It affects the 3d view and the 2d view.Corrected data: - b4 date of this report.- 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.
 
Event Description
The surgeon brought up several issues with the new planning software on her laptop.On the robot, during the case we were attempting to look at the mr image for confirmation.When attempting to look at the mr, it was completely blank.The exam manager would say that the mr was selected on both the 3d and as one of the images, but the 3d rendering would never show up, and if you scrolled to the mr between the scans it would be blank.This image would show up on the planning station, but when transferred over, the mr would be blank yet still recognized on the robot.
 
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Brand Name
ROSA ONE
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 Key10579898
MDR Text Key208415625
Report Number3009185973-2020-00219
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
PMA/PMN Number
K200511
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberROSA ONE
Device Catalogue NumberROSAS00203
Device Lot Number3.1.4.1650
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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