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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 Data Problem (3196)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/07/2020
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.(b)(4).
 
Event Description
Unable to compute registration from mri, the field service engineer explained that ct was best for contactless registration, but surgeon wanted to proceed.Surgeon feedback provided that there should be an option to calculate or estimate is the 3d reconstruction is sufficient for registration based off image quality, and when registration fails it should show the points that are failing.
 
Manufacturer Narrative
A full analysis of the data logs has been performed and this analysis concluded that the registration failed because the scan was interrupted by a timeout error.The device detected that the scan loop lasted over the threshold limit and that an error occurred in the controller, which provoked the device shutdown.However, the analysis of the controller log did not permit to identify this error and determine whether it triggered the issue; therefore the technical root cause of the event remains undetermined.However the device behaved as expected and as specified, as the error detected in the controller provoked the shutdown of the device.
 
Event Description
Unable to compute registration from mri, the field service engineer explained that ct was best for contactless registration, but surgeon wanted to proceed.Surgeon feedback provided that there should be an option to calculate or estimate is the 3d reconstruction is sufficient for registration based off image quality, and when registration fails it should show the points that are failing.
 
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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 Key10338142
MDR Text Key205309498
Report Number3009185973-2020-00183
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
PMA/PMN Number
K182417
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2020
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 Number3.1.1.1295
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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