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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
Device Problems Computer Software Problem (1112); Unintended Collision (1429)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/30/2019
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
The patient was pinned in a mayfield head holder (3 pin fixation), attached to the robot, and registered using bone fiducials.The robot was driven to the 12th trajectory and the field service engineer noticed that joint 5 was close to the patient's head holder, so the arm was put in axial slow and the surgeon was told to be mindful of how close the arm got to the head frame.The arm was pushed into the head holder attachment which caused the robot to show a communication failure message.The system walked through saving the patient folder and shutting the system down.The system was restarted, but when trying to connect to the controller, there was another communication failure.This occurred twice.It was noted that there must be too much force applied to the joint that was causing this failure.No cords were pinched, so the drapes were pulled up so that the team could see what the arm was hitting.It was pressed against the mayfield adaptor handle.The surgeon was able to turn the handle slightly, which released the pressure.The system was restarted and the arm connected with no trouble and the last two trajectories were placed after changing the angle of approach of the trajectories.In total, this caused about a 15 minute delay in the case.The post-op scan showed great accuracy.
 
Manufacturer Narrative
Dhr review and review of complaint history did not identify any contributory factors to the event.A full analysis of the data logs could not be performed due to missing data, despite multiple attempt to retrieve them.The controller log was provided but cannot be utilized without the software logs.Analysis showed that event is non-verifiable.However, based on the complaint description, a collision was performed by the user which led to a communication error.The vigilance device was not properly managed and should have been released to avoid collision.A warning was provided by the field service engineer assisting the surgery to the surgeon before the collision happens.Corrected data: b4 date of this report.D4 catalog number.G4 date received by manufacturer.H2 if follow-up, what type.H3 device evaluated by manufacturer.H6 event problem and evaluation codes.
 
Event Description
The patient was pinned in a mayfield head holder (3 pin fixation), attached to the robot, and registered using bone fiducials.The robot was driven to the 12th trajectory and the field service engineer noticed that joint 5 was close to the patient's head holder, so the arm was put in axial slow and the surgeon was told to be mindful of how close the arm got to the head frame.The arm was pushed into the head holder attachment which caused the robot to show a communication failure message.The system walked through saving the patient folder and shutting the system down.The system was restarted, but when trying to connect to the controller, there was another communication failure.This occurred twice.It was noted that there must be too much force applied to the joint that was causing this failure.No cords were pinched, so the drapes were pulled up so that the team could see what the arm was hitting.It was pressed against the mayfield adaptor handle.The surgeon was able to turn the handle slightly, which released the pressure.The system was restarted and the arm connected with no trouble and the last two trajectories were placed after changing the angle of approach of the trajectories.In total, this caused about a 15 minute delay in the case.The post-op scan showed great accuracy.
 
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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 Key8933899
MDR Text Key201404400
Report Number3009185973-2019-00287
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
PMA/PMN Number
K172444
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberROSA BRAIN
Device Catalogue NumberROSAS00303
Device Lot Number3.0.0.21
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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