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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Coma (2417)
Event Date 09/20/2017
Event Type  Injury  
Manufacturer Narrative
The investigation performed on surgery data log files pointed out that the device worked as intended, also according to the surgeon the haemorrhage is not related to the device usage but to patient anatomy.
 
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.
 
Event Description
It was reported that four hours after the surgery a hemorrhage was noticed in a patient. It was reported that the surgeon verified all entry point and target point errors were minimal and stated that he did not believe that the rosa device caused the hemorrhage.
 
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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 Key6975514
MDR Text Key114185702
Report Number3009185973-2017-00745
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
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 Inspection
Type of Report Initial,Followup
Report Date 03/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberROSA BRAIN 3.0
Device Catalogue NumberBR16010
Device Lot Number3.0.0.20
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 Received03/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/06/2016
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: 10/25/2017 Patient Sequence Number: 1
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