Model Number ROB10024 |
Device Problem
Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/02/2022 |
Event Type
malfunction
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Event Description
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It was reported that, during a cori assisted surgery, the real intelligence cori froze.It is unknown how the procedure was completed and if there was any delay.The patient outcome is unknown.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Manufacturer Narrative
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Sections b5, d3 and h6 were updated according to the new information received.Internal complaint reference number: (b)(4).
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Event Description
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It was reported that, during a cori assisted surgery, the real intelligence cori froze.The procedure was completed with the main monitor without significant delays.The patient was not harmed.
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Manufacturer Narrative
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H3, h6.The real intelligence cori, part number rob10024, serial number (b)(6), used for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing records indicate the device met all specifications upon release into distribution.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with emi interference causing tablet to flicker.Based on the investigation, the need for a corrective action is not recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.
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Search Alerts/Recalls
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