Model Number ROSA ONE 3.1 |
Device Problems
Manufacturing, Packaging or Shipping Problem (2975); Problem with Software Installation (3013)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 04/20/2018 |
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 will be performed, a follow-up medwatch report will be submitted.The device model rosa one is not fda cleared but is similar to the device rosa brain 3.0, classified haw and cleared under k151359 / k172444.(b)(4).
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Event Description
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It was reported that during a surgery the patient folder could not be loaded on the robot pc from the planning station as the planning station and the robot pc have different licenses.
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Manufacturer Narrative
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It was reported that the surgeon was not able to load the patient folder in the robot.A dhr review and a complaint history review were performed and did not identify any contributory factors to the event.Technical investigation concluded that the cause of the issue is a discrepancy between options installed on the rosa one pc and the laptop.Based on the technical investigation performed the root cause identified is a manufacturing non-conformity.The device model rosa one is not fda cleared but is similar to the device rosa brain 3.0, classified haw and cleared under k172444.(b)(4).
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Event Description
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On the (b)(6) 2018, during an assisted surgery the planning performed on the planning station could not be loaded into the rosa one pc.It is at this time that cst and surgeon noticed that there was a discrepancy between licenses installed on the planning station and on the robot.The cst modified manually the patient folder so that it could be used and opened on the or on the robot pc.
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Search Alerts/Recalls
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