Model Number ROSA ONE |
Device Problem
Data Problem (3196)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/27/2018 |
Event Type
malfunction
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Manufacturer Narrative
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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.The device has not been evaluated yet for investigation purpose.Once the evaluation will be performed, a follow-up medwatch report will be submitted.
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Event Description
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It was reported that the robot was unable to load the patient data just before a surgery.This data was previously exported from the computer for pre-op planning.Consequently, the surgery planning had to be redone on the robot.There was a reported delay of about 10 minutes to redo the planning and restart the system.
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Manufacturer Narrative
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It was reported that the surgeon needed to re-do the planning on the rosa pc because he could not load the patient data previously exported from the planning station.A dhr review and a complaint history review were performed and did identify 1 similar complaint which had occurred one week before.A full analysis of data log has been performed and indicates that the cause of the issue is a discrepancy between options installed on the rosa pc and the computer for pre-op planning.Based on the technical investigation performed the root cause identified is a manufacturing non-conformity which is being further investigated internally.Unique identifier (udi)#: (b)(4).Corrected data: date of this report.Date received by manufacturer.If follow-up, what type.Device evaluated by manufacturer.Evaluation code.
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Search Alerts/Recalls
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