Model Number ROSA ONE |
Device Problem
Positioning Failure (1158)
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Patient Problem
Intracranial Hemorrhage (1891)
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Event Date 11/10/2021 |
Event Type
Injury
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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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It was reported that it was completed a 13 trajectory bilateral seeg case using the rosa robot with a company representative present.The patient was put to sleep, pinned in a mayfield head clamp, attached to rosa and registered using contactless registration.All 13 trajectories were placed as normal.The company representative then received an email the next day from the surgeon stating that the patient had a brain hemorrhage that was seen on a post operative ct scan.The information that was given was that the majority of the electrodes were placed correctly, but a couple were off target.
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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 detailed analysis of the data logs has been performed, and revealed that the fusion of the post-operative ct to the pre-operative ct had not been performed properly by the user.However, proper fusion results could not be achieved using a rosa simulator during our investigations; consequently, the actual placement of the electrodes could not be reviewed and the inaccuracy cannot be confirmed.However, our review of available files did not suggest any issue with the registration process, the pre-operative fusion or the rosa log files.No failure of the device or user error is suspected.The reported inaccuracy remains unconfirmed.
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Event Description
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It was reported that it was completed a 13 trajectory bilateral seeg case using the rosa robot with a company representative present.The patient was put to sleep, pinned in a mayfield head clamp, attached to rosa and registered using contactless registration.All 13 trajectories were placed as normal.The company representative then received an email the next day from the surgeon stating that the patient had a brain hemorrhage that was seen on a post operative ct scan.The information that was given was that the majority of the electrodes were placed correctly, but a couple were off target.
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Search Alerts/Recalls
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