Model Number ROB10027 |
Device Problem
No Display/Image (1183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/08/2022 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Event Description
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It was reported that before a cori assisted ukr procedure, the real intelligence tablet would remain constantly black, and the indicator light on the front of the tablet flashes green and orange alternately.The indicator light on the cori control unit lights up white all the time.Procedure continued with manual instruments, without a delay or injury.
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Manufacturer Narrative
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H3, h6: the real intelligence tablet, part number rob10027, serial number (b)(6), intended for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.Log files although submitted would have no information to add to the investigation.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.Refer to the real intelligence cori for knee arthroplasty user manual, section getting started: real intelligence¿ cori¿ quick start guide, connecting the components for proper set up and handling.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 tablet failure.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.Internal complaint reference number: (b)(4).
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Manufacturer Narrative
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The real intelligence tablet, part # rob10027, serial # (b)(6), intended for use in treatment, was returned for evaluation.A relationship between the reported event and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.Tests found that the touchscreen and backlighting of the tablet are functioning normally, but the video display is not receiving signal.The most likely cause is a faulty internal displayport connection for the tablet's screen or malfunctioning video board in the tablet.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found similar events.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.Refer to the real intelligence cori for knee arthroplasty user manual, section getting started: real intelligence¿ cori¿ quick start guide, connecting the components for proper set up and handling.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Although no further containment or corrective action is recommended or required at this time, the failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.Internal complaint reference number: (b)(4).
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Search Alerts/Recalls
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