Model Number ROSA 2.5.8 |
Device Problems
Computer Software Problem (1112); Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
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Event Date 06/18/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Udi# : not applicable.The device has not been evaluated yet for investigation purpose.Once the evaluation is performed, a follow-up medwatch report will be submitted.
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Event Description
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The (b)(6) distributor reported that: 'ro16083 was installed in (b)(6); (b)(6) 2020.It appeared the same errors in 7 seeg surgeries.The dates are: (b)(6) 2020.As the doctor told me,the system would shut down almost every trajectory.'.
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Manufacturer Narrative
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Dhr review and review of complaint history did not identify any contributory factors to the event.A full analysis of the data logs for this event and for the other complaints related to the same issue/device has been performed and revealed that the reported event possibly results from a problem with the operation of the foot pedal due to electromagnetic interferences.The surgeon was reportedly using an electrocautery device during these surgeries, which could be at the origin of these electromagnetic interferences.A review of the ifus was performed and the user manual indicates that an usage of accessories, transducers and cables could result in increased electromagnetic emissions or decreased electromagnetic immunity of the robot and could result in improper operation.Based on available information, the root cause of the event could not be conclusively determined.Corrected data: b4 date of this report.G4 date received by manufacturer.H2 if follow-up, what type.H3 device evaluated by manufacturer.H6 event problem and evaluation codes.H10 additional narratives/data.
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Event Description
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The chinese distributor reported that: '(b)(6) was installed at (b)(6) hospital on (b)(6) 2020.It appeared the same errors in 7 seeg surgeries.The dates are (b)(6) 2020.The system would shut down almost every trajectory.'.
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Search Alerts/Recalls
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