Catalog Number NPFS02020 |
Device Problem
Unintended Application Program Shut Down (4032)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/10/2020 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference (b)(4).Article cite: mergenthaler, g., batailler, c., lording, t., servien, e., & lustig, s.(2021).Is robotic-assisted unicompartmental knee arthroplasty a safe procedure? a case control study.Knee surgery, sports traumatology, arthroscopy : official journal of the esska, 29(3), 931¿938.Https://doi.Org/10.1007/s00167-020-06051-z.
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Event Description
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It was reported that, on the literature review "is robotic-assisted unicompartmental knee arthroplasty a safe procedure? a case control study", four (4) uka procedures assisted with a blue belt navio robotic surgical system were aborted and completed with conventional instrumentation.One (1) of these cases was aborted due to a software crash.No additional details were provided in regards of the software application issue experienced.No further information is available.
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Manufacturer Narrative
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The navio surgical system be/fr/de, part number npfs02020, 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.While all products meet required manufacturing specifications prior to release a serial number, lot number, part revision or software version is required to link the device to a dhr or nc investigation.If a navio¿ surgical system failure occurs at any point during the surgical case, refer to the surgical technique guide for knee arthroplasty, recovery procedure guidelines tables for proper guidance regarding recovering to a fully manual procedure.A failure can consist of, but is not limited to, a system software crash, unrecoverable hardware failure, handpiece failure with no backup available, tracker array failure or loss of contact with bone that is unrecoverable, etc.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.Internal complaint reference number: (b)(4).
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Search Alerts/Recalls
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