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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 Problems Computer Software Problem (1112); Protective Measures Problem (3015)
Patient Problem No Patient Involvement (2645)
Event Date 10/25/2019
Event Type  malfunction  
Manufacturer Narrative
(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
The field service engineer (fse) was present for a seeg case at (b)(6) medical center (adult hospital) in (b)(6). Before the case, cst tested the arm and there was a robot shutdown due to a communication failure at 3:09 pm. The fse realized that the emergency stop button was on (lit up red). Once that was resolved, and the robot was unplugged and restarted, there were no issues.
 
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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 Key9340552
MDR Text Key199504723
Report Number3009185973-2019-00408
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 02/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/19/2019
Is this an Adverse Event Report? No
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 Received02/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/14/2018
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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