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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTECH SA ROSA BRAIN; COMPUTER-ASSISTED SURGICAL DEVICE
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MEDTECH SA ROSA BRAIN; COMPUTER-ASSISTED SURGICAL DEVICE Back to Search Results
Model Number ROSA BRAIN 3.0
Device Problems Computer Software Problem (1112); Unintended Collision (1429)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/18/2019
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. .
 
Event Description
When driving to trajectory in guidance mode with sterile instrument holder attached, robot arm collided with the mayfield adaptor (mayfield frame was pinned in mohawk position).After two restart attempts, surgery was continued.Later on, another shutdown occurred without explanation while driving to trajectory.No apparent collision or pinched cables.
 
Manufacturer Narrative
It was reported that a collision followed by two restart attempts occurred and then, another shutdown occurred while driving to trajectory.A dhr review and a complaint history review were performed and did not identify any contributory factors to the event.The full analysis of data logs confirmed that 3 errors occurred.The 1st communication error was due to the collision.The ifu provides indications on how to prevent collisions with the vigilance device pedal, therefore it is considered as use error.The 2nd communication error has been determined to be a normal device behavior following collision while the 3rd shutdown was due to a misconfiguration of the stop button variable in the source code.Correction : in the initial report it was noted that the notification is 19 mar 2019 however the correct date is 18 mar 2019.This correction does not appear in the subject report as the date entered in section g4 corresponds to the date the investigation was completed and investigation results were available.
 
Event Description
When driving to trajectory in guidance mode with sterile instrument holder attached, robot arm collided with the mayfield adaptor (mayfield frame was pinned in mohawk position).After two restart attempts, surgery was continued.Later on, another shutdown occurred without explanation while driving to trajectory.No apparent collision or pinched cables.
 
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Brand Name
ROSA BRAIN
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 Key8495131
MDR Text Key141493872
Report Number3009185973-2019-00128
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
PMA/PMN Number
K151359
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberROSA BRAIN 3.0
Device Catalogue NumberROSA BRAIN
Device Lot Number3.0.0.21
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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