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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 Problem Mechanical Problem (1384)
Patient Problem No Code Available (3191)
Event Date 12/14/2017
Event Type  Injury  
Manufacturer Narrative
The analysis of data logs confirmed that the initiation process of the controller was not running. Thus, a field service technician changed the starc board to another slot. This intervention solved the issue. A review of qms support processes was performed and this determined that there is an existing capa related to issues of connection with the starc board. This capa determined that there may be a problem with the starc card, this component being provided by a supplier. Root cause: the starc board contact may not be robust enough.
 
Manufacturer Narrative
The device has not been evaluated yet for investigation purpose. Once the evaluation will be performed, a follow-up medwatch report will be submitted. Patient code (b)(4)- no code available' was selected as there was a delay greater than 30 minutes on the surgery due to this event, then the surgery was converted to a traditional surgery performed without the (b)(6) brain device.
 
Event Description
It was reported that the surgeon was not able to connect the robot to (b)(6), as he was begining a brain biopsy. A medtech field service engineer went on site to investigate and changed the position of the starc board inside the controller's module which resolved the issue.
 
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Brand NameROSA BRAIN
Type of DeviceCOMPUTER-ASSISTED SURGICAL DEVICE
Manufacturer (Section D)
MEDTECH SA
zac eureka
900 rue du mas de verchant
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 Key7133183
MDR Text Key250774152
Report Number3009185973-2017-00830
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
PK151359
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Repair
Type of Report Initial,Followup
Report Date 04/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberROSA BRAIN 3.0
Device Catalogue NumberN/A
Device Lot NumberN/A
Other Device ID NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/23/2016
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

Patient Treatment Data
Date Received: 12/20/2017 Patient Sequence Number: 1
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