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Model Number ROSA ONE
Device Problem Malposition of Device (2616)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/30/2019
Event Type  malfunction  
Manufacturer Narrative
Unique identifier (udi) #: (b)(4). A full analysis of the logs and of the patient folder has been performed. The ten electrodes have been implanted with an inaccuracy superior to 2 mm at their entry point. The different deviations of the electrodes do not allow to identify a trend. One of the possible explanation to the deviations that have been observed is that the registration performed was not sufficiently accurate. This can be due to the fact that a 3t mri was used as 3d reference for the laser registration (which is not recommended in the ifus due to the risk of distortion of the image) or to the fact that the user did not recollect a point with the robot arm after he adjusted its position on the image. The user also validated the laser registration although an insufficient number of points matched. Finally, the numerical results of the verification showed that three of the eight verified points had an error distance exceeding the threshold and triggered a warning message. Because the verification screenshots were not available, it is impossible to confirm that the verification was performed correctly which would have ensured that the registration was accurate. However, it is not possible to conclude that the incorrect registration caused the deviations at the entry point of the ten electrodes. Based on the investigation performed, the technical root cause of the event was determined to be use error - use of a 3t mri as reference.
Event Description
This was an issue that was brought up by surgeon regarding using mri for laser registration. This site along with the company representative have been using the mri images to register patients for seeg. The surgeon brought up that his bolts were displaced vertically relative to his plan. During the post op scan, he would see that the bolt was placed a few mm away from where he initially planned. All bolts appear to be placed with this error. The surgeon requested more information into why this error is occurring. He is aware that our company does not recommend using mr for laser registration, but he would like to know why his accuracy is affected regardless. If needed, he will switch to using a ct.
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Brand NameROSA ONE
Manufacturer (Section D)
zac eureka
900 rue du mas de verchant
montpellier, languedoc-roussillon 34000
FR 34000
Manufacturer (Section G)
zac eureka
900 rue du mas de verchant
montpellier, languedoc-roussillon 34000
FR 34000
Manufacturer Contact
jay sharma
1520 tradeport drive
jacksonville, FL 32218
MDR Report Key11371738
MDR Text Key233566202
Report Number3009185973-2021-00055
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
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 02/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROSA ONE
Device Catalogue NumberROSAS00203
Device Lot Number3.1.1.1295
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 Received01/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/04/2018
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