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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 Unintended Collision (1429)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/22/2020
Event Type  malfunction  
Manufacturer Narrative
(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
During seeg case, registration and verification had proceeded normally.Surgeon had noted that trajectories were to be done in an order other than was indicated by rosa planning software.The field service engineer (fse) had driven to first trajectory on list, but another trajectory was desired by surgeon.The fse confirmed with resident that rosa arm was clear and was instructed to move towards next trajectory.Collision with leksell frame occurred; resident indicated that they were unaware that arm was close enough to cause collision.Rosa detected collision, and shutdown was necessary.Rosa was re-started, and surgeon educated resident on importance of stopping movement with vigilance device and clearing arm properly before automatic movements.The fse recommended that registration be repeated to ensure accuracy.Patient was under anesthesia, no incision had been made.Delay less than 10 minutes.Registration performed again and case proceeded normally; electrode placement was accurate.
 
Manufacturer Narrative
Dhr review and review of complaint history were not performed based on the low severity of this complaint.A full analysis of the data logs permitted to confirm that the collision occurred during a clearance procedure and that registration has been re-started after the event as described in the complaint description.No inaccuracy has been found by the user following the case.This event can be considered as a use error as the user manual provides all information to avoid collisions.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.
 
Event Description
During seeg case, registration and verification had proceeded normally.Surgeon had noted that trajectories were to be done in an order other than was indicated by rosa planning software.The field service engineer (fse) had driven to first trajectory on list, but another trajectory was desired by surgeon.The fse confirmed with resident that rosa arm was clear and was instructed to move towards next trajectory.Collision with leksell frame occurred; resident indicated that they were unaware that arm was close enough to cause collision.Rosa detected collision, and shutdown was necessary.Rosa was re-started, and surgeon educated resident on importance of stopping movement with vigilance device and clearing arm properly before automatic movements.The fse recommended that registration be repeated to ensure accuracy.Patient was under anesthesia, no incision had been made.Delay less than 10 minutes.Registration performed again and case proceeded normally; electrode placement was accurate.
 
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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 Key9731348
MDR Text Key200847632
Report Number3009185973-2020-00059
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 03/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2020
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 Received03/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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