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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 3.1
Device Problem Unintended Collision (1429)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/20/2021
Event Type  malfunction  
Manufacturer Narrative
Unique identifier (udi) #: (b)(4). A full analysis of the data logs has been. This analysis concluded the collision between the arm of the robot and the telescopic arm caused an excessive torque in the first joint of the robot. This triggered an error with the controller and the shutdown of the device. It is a normal behavior of the device. The release of the vigilance device could have avoided the collision, as indicated in the instructions for use. The user restarted the device and resumed the procedure.
 
Event Description
During an seeg case, there was a shut down during registration. The surgeon had planned a unilateral seeg case. The patient was positioned supine with a slight head tilt. A fellow was registering for the case when the robot shut down due to the robotic arm running into the telescopic arm. There was less than 10 minutes of delay as the rosa was shut down, turned off, and restarted. After the shutdown, the patient was registered using the pins on the leksell frame, and accuracy was checked using bone fiducials and facial features. There were no further shut downs during the case.
 
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Brand NameROSA ONE
Type of DeviceCOMPUTER-ASSISTED SURGICAL DEVICE
Manufacturer (Section D)
MEDTECH SA
zac eureka
900 rue du mas de verchant
montpellier, languedoc-roussillon 34000
FR 34000
Manufacturer (Section G)
MEDTECH SA
zac eureka
900 rue du mas de verchant
montpellier, languedoc-roussillon 34000
FR 34000
Manufacturer Contact
jay sharma
1520 tradeport drive
jacksonville, FL 32218
9047414400
MDR Report Key11243837
MDR Text Key229302593
Report Number3009185973-2021-00027
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200511
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROSA ONE 3.1
Device Catalogue NumberROSAS00203
Device Lot Number3.1.4.1650
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/08/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

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