Model Number ROSA ONE |
Device Problem
Positioning Problem (3009)
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Patient Problem
Insufficient Information (4580)
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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.Unique identifier (udi) #: (b)(4).
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Event Description
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Among the last seegs that we carried out with the rosa one, on two seegs we observed quite significant deviations (between 3 and 4mm on the orthogonal plane) of the electrodes compared to the planned trajectories.Yet the interventions were both without any technical concerns.
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Event Description
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Among the last seegs that we carried out with the rosa one, on two seegs we observed quite significant deviations (between 3 and 4mm on the orthogonal plane) of the electrodes compared to the planned trajectories.Yet the interventions were both without any technical concerns.
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Manufacturer Narrative
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Due to the fact that the event date was not provided, no investigation could be performed on the event described.More than three follow-up has been made to get the event date and patient impact without answer.If any relevant information or data is provided, the complaint will be re-open for analysis.The event described in the complaint is not confirmed.H3 other text: no investigation could be performed.
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Search Alerts/Recalls
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