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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 OPTICAL DISTANCE SENSOR
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Patient Involvement (2645)
Event Date 09/12/2019
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.(b)(4).
 
Event Description
While performing an accuracy check using kineverif software, the optical distance sensor was connected.The laser initially turned on but when the robot arm moved towards the sphere, the laser turned off.The process was repeated and the distance sensor accuracy check got about halfway done before the laser turned off again.The accuracy check was done with a different optical distance sensor to confirm whether it was the robot or the distance sensor, and the second distance sensor worked fine.No patient was involved.
 
Event Description
While performing an accuracy check using kineverif software, the optical distance sensor was connected.The laser initially turned on but when the robot arm moved towards the sphere, the laser turned off.The process was repeated and the distance sensor accuracy check got about halfway done before the laser turned off again.The accuracy check was done with a different optical distance sensor to confirm whether it was the robot or the distance sensor, and the second distance sensor worked fine.No patient was involved.
 
Manufacturer Narrative
It was reported that during preventive maintenance, the laser of the optical distance sensor worked intermittently.Dhr review and review of complaint history were not performed based on the low severity of this complaint.A full analysis of the returned optical distance sensor has been performed.Visual inspection showed that no damage is visible.Functional test showed that the optical distance sensor worked intermittently and eventually did not work anymore.It was decided to check the connections of the optical distance sensor and it was found that one of the connector was disconnected.This is the root cause of the connection issues.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
While performing an accuracy check using kineverif software, the optical distance sensor was connected.The laser initially turned on but when the robot arm moved towards the sphere, the laser turned off.The process was repeated and the distance sensor accuracy check got about halfway done before the laser turned off again.The accuracy check was done with a different optical distance sensor to confirm whether it was the robot or the distance sensor, and the second distance sensor worked fine.No patient was involved.
 
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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 Key9127890
MDR Text Key196264169
Report Number3009185973-2019-00321
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
Type of Report Initial,Followup,Followup
Report Date 01/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberOPTICAL DISTANCE SENSOR
Device Catalogue NumberROSAS00316
Device Lot NumberROSA3-277B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2019
Was the Report Sent to FDA? No
Date Manufacturer Received01/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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