Model Number ROSA BRAIN 3.0 |
Device Problem
Defective Component (2292)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/04/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been evaluated yet for investigation purpose.Once the evaluation is performed, a follow-up medwatch report will be submitted. udi# : ((b)(4).
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Event Description
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After seeg surgery on (b)(6) 2019, cst on site noticed that the deported pc button was not working and did not show the blue light to indicate that it was functioning.This was noticed after the surgery and had no effect on the patient.The surgery was unaffected.No logs were obtained as the issue appeared to be hardware related and not affected by the controller or rosanna/mario software.
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Manufacturer Narrative
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It was requested to check the state of deported pc button wire.After a check of the electrical wire connection by the field service engineer, he observed that the deported button wires were disconnected when he opened up the robot.The deported button worked again as the fse put wires back together.Device is now fully functional, no new event related to this issue has been reported since this event.
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Event Description
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After seeg surgery on (b)(6) 2019, the field service engineer on site noticed that the deported pc button was not working and did not show the blue light to indicate that it was functioning.This was noticed after the surgery and had no effect on the patient.The surgery was unaffected.
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Search Alerts/Recalls
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