Model Number ROB10024 |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/21/2022 |
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, during a cori assisted surgery, there were several bad drill issues, it is believed that the issue comes from the console.The procedure was completed, with a delay of less than 30 min, changing to manual procedure.Patient was not harmed.
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Manufacturer Narrative
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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 real intelligence cori for knee arthroplasty user manual ((b)(4)) provides guidelines for recovering to a fully manual procedure in the "recovery procedure guidelines, appendix d".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 console software bug.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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Manufacturer Narrative
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H3, h6: the real intelligence cori, part number rob10024, serial number (b)(6), used for treatment, was returned for evaluation.The reported problem could not be confirmed with a visual inspection.The reported problem was not confirmed with a functional evaluation.Test cases and kpc diagnostics were completed without errors with 2 lab drills.A review of the log files and screenshots confirmed the event.Numerous drill errors occurred across multiple cases.A relationship between the reported event and the device could not be established.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with faulty drills/drill attachments being used during the cases.No issues were found with the console.Drill (b)(6) was returned on a different complaint (same day of event) and it was found that the drill attachment retaining nut was loose, which may have caused the failures present in the logs.Refer to the real intellignece cori for knee arthroplasty user manual for guidance to recover to a manual case in the event of a system failure.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.A historical review concluded that no prior escalation actions are applicable to the scope of the reported complaint.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.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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Manufacturer Narrative
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H3, h6.The real intelligence cori, part number rob10024, serial number (b)(6), used for treatment, was returned for evaluation.The reported problem could not be confirmed with a visual inspection.The reported problem was not confirmed with a functional evaluation.Test cases and kpc diagnostics were completed without errors with 2 lab drills.A review of the log files and screenshots confirmed the event.Numerous drill errors occurred across multiple cases.A relationship between the reported event and the device could not be established.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with faulty drills being used during the cases.No issues were found with the console.Refer to the real intellignece cori for knee arthroplasty user manual for guidance to recover to a manual case in the event of a system failure.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.A historical review concluded that no prior escalation actions are applicable to the scope of the reported complaint.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.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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