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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 Protective Measures Problem (3015)
Patient Problem No Patient Involvement (2645)
Event Date 10/28/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). It was reported that upon starting of the device, the emergency light button was turned on with no reason. Dhr review and review of complaint history were not performed based on the low severity of this complaint. According to technical investigation the red emergency light w as on at the device initiation because the controller did not initiate. The device behaved as expected as it showed that the controller required to be rebooted. The issue is due to the scr version used in controller. The issue w as already analyzed as a supplier non-conformity.
 
Event Description
A field service engineer (fse) assisted a surgeon with an ablation/biopsy case at (b)(6) on (b)(6) 2019 using br18054. Before the case started, the fse arrived early to get patient images sent to the robot through pacs. When the fse turned the robot on around 6:44am est, the emergency button red light turned on and stayed on. The button was not pressed, and also did not appear to be engaged. After obtaining the patient imaging through pacs and creating the patient folder, the robot was restarted. After waiting one minute before turning the robot back on, the fse turned the robot on and the emergency button was no longer red. The fse did not touch the emergency button at all even before restarting. Nothing should have been different, yet the red light only turned on the first time the robot was turned on. This occurred before the surgeon and patient were in the or, so no delay to surgery.
 
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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 Key9374712
MDR Text Key200851227
Report Number3009185973-2019-00411
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
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 11/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberROSA BRAIN
Device Catalogue NumberROSAS00303
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 Received10/28/2019
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

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