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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
Device Problem Image Orientation Incorrect (1305)
Patient Problem No Code Available (3191)
Event Date 06/18/2019
Event Type  Injury  
Manufacturer Narrative
Udi# : (b)(4). The device has not been evaluated yet for investigation purpose. Once the evaluation is performed, a follow-up medwatch report will be submitted.
 
Event Description
An airo ct was taken of the patient in the prone position. The ct was transferred onto a usb and loaded onto the robot. An automatic merge was performed; however, the merge was unsuccessful. It appeared that the ct was fully rotated on the axis and over 45 degrees off from the mri. The merge was performed twice more with cutting extra slices on the top and bottom of the set; however, this did not work. A semi-automatic merge was attempted with 5 points, but this made the image worse. It was confirmed that the airo options for prone and axial ct had been selected. Another mri was loaded onto the patient (this one of a sagittal view) and merged to the original mri on the plan. The ct was then merged to this second mri and was able to merge successfully. The surgeon was upset that the software could not perform the automatic merge itself and that there was no option to align the two images partially and allow the software to do the automatic merge from that point. A delay of over an hour occurred during this time while the patient was under anesthesia. This was an rns case.
 
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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
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 Key8795376
MDR Text Key151195878
Report Number3009185973-2019-00244
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172444
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,Followup
Report Date 09/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROSA BRAIN
Device Catalogue NumberN/A
Device Lot Number3.0.0.21
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 Received08/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/10/2018
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

Patient Treatment Data
Date Received: 07/16/2019 Patient Sequence Number: 1
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