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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 VIGILANCE DEVICE PEDAL
Device Problem Defective Component (2292)
Patient Problem No Code Available (3191)
Event Date 05/29/2019
Event Type  Injury  
Manufacturer Narrative
The device has not been evaluated yet for investigation purposes.Once the evaluation is performed, a follow-up medwatch report will be submitted.
 
Event Description
The procedure was a shunt case and one trajectory.Surgeon and field service engineer were just making sure that the foot pedal would work, since this has been a reoccurring issue, so the patient hadn't yet been pinned or attached to the robot.The surgeon planned on doing contactless registration so he selected that option.The "boom, click" sound of the robot connecting to the controller was heard.Surgeon and field service engineer were then given the prompt on the screen to step on the foot pedal so the arm would go to the home position.When the surgeon stepped on the foot pedal/vigilance device the prompt came up that he had taken our foot off the pedal (not true) and then he cycled through the steps to try to move the arm.Surgeon and field service engineer couldn't resolve this issue.So they restarted the robot.They repeated these exact steps, plus additionally unplugging/replugging the vigilance device into the robot 4 times.None of the attempts worked.Surgeon and field service engineer came to the collective decision to not try again and proceed to the case without using rosa (possible in this situation).There was no medical intervention and there was no delay to the start of the procedure.
 
Event Description
The procedure was a shunt case and one trajectory.Surgeon and field service engineer were just making sure that the foot pedal would work, since this has been a reoccurring issue, so the patient hadn't yet been pinned or attached to the robot.The surgeon planned on doing contactless registration so he selected that option.The "boom, click" sound of the robot connecting to the controller was heard.Surgeon and field service engineer were then given the prompt on the screen to step on the foot pedal so the arm would go to the home position.When the surgeon stepped on the foot pedal/vigilance device the prompt came up that he had taken our foot off the pedal (not true) and then he cycled through the steps to try to move the arm.Surgeon and field service engineer couldn't resolve this issue.So they restarted the robot.They repeated these exact steps, plus additionally unplugging/replugging the vigilance device into the robot 4 times.None of the attempts worked.Surgeon and field service engineer came to the collective decision to not try again and proceed to the case without using rosa (possible in this situation).There was no medical intervention and there was no delay to the start of the procedure.
 
Manufacturer Narrative
It was reported that during a surgery, when the vigilance device was pressed, the software gave a message asking to press the vigilance device several times.Surgery was then converted to traditional surgery.Dhr review did not identify any contributory factors to the event.Review of complaint history showed that two similar complaints were received with the same root cause.According to technical investigation the issue was caused by a faulty wiring of the connector of the vigilance device.This connector was replaced.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.
 
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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 Key8734995
MDR Text Key149209144
Report Number3009185973-2019-00222
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 03/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberVIGILANCE DEVICE PEDAL
Device Catalogue NumberROSAP00535
Device Lot Number1330859
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Other;
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