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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 Problems Malposition of Device (2616); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/16/2020
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.Unique identifier (udi) #: (b)(4).
 
Event Description
At the end of the case, merging the ct scan and the mri and comparing the electrodes to the plan, it was found that the entry points of the electrodes were all slightly deviated from the plan.The surgeon inferred that there most likely was a merge issue, due to the fact the post-op ct did not include the entire top of the head.The surgeon was fine with placement of electrodes and the case concluded successfully, however even after the case when the company representative tried to adjust the merge, the ct and mri still could not be adjusted and entry points of the electrodes remained off by the same amount in the same direction.
 
Event Description
At the end of the case, merging the ct scan and the mri and comparing the electrodes to the plan, it was found that the entry points of the electrodes were all slightly deviated from the plan.The surgeon inferred that there most likely was a merge issue, due to the fact the post-op ct did not include the entire top of the head.The surgeon was fine with placement of electrodes and the case concluded successfully, however even after the case when the company representative tried to adjust the merge, the ct and mri still could not be adjusted and entry points of the electrodes remained off by the same amount in the same direction.
 
Manufacturer Narrative
A full analysis of the data logs has been performed.This analysis concluded that the inaccuracy is confirmed for all fourteen trajectories at the entry points.The deviation analysis suggests a rotation of the head.The registration was validated with multiple use errors which could impact the registration accuracy : the exam used for the laser registration was a 3t mri which is specifically not recommended in the instructions for use as it creates distortion.All initial points were corrected on image only and not with the robot arm as specified in the instructions for use.The last point was validated with an important error detected during the verification step.Visually the point was also incorrect, thus the verification step should have been restarted.The deviations observed might be the result of an inaccurate patient registration due to the above described use errors.An inelastic movement of the head is not likely since a leksell frame was used with a leksell adaptor during the case.The analysis shows that the device behaved as expected.The final ct post-operative merged during the case does not show the entire head due to a contrast issue.The results could not be checked properly.However, the merge was attempted on manufacturing site and was successful, which permitted to complete the analysis.Corrected data: b1 report type, 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.
 
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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 Key11011674
MDR Text Key221752901
Report Number3009185973-2020-00315
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 03/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
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 Received03/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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