Model Number 219999 |
Device Problem
Application Program Problem: Parameter Calculation Error (1449)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.
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Event Description
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Mps reported new system is lagging, green not going away in cuts, and unable to export session files.Case completed robotically.Update: no noticeable surgical delay.Less that minute.Tka.
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Event Description
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Mps reported new system is lagging, green not going away in cuts, and unable to export session files.Case completed robotically.Update: no noticeable surgical delay.Less that minute.Tka.
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Manufacturer Narrative
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Reported event: an event regarding computer failure involving a mako robotic arm was reported.The event was confirmed.Method & results: product evaluation and results: the field service engineer reported: problem reproduced? yes.Trouble shooting notes: none.Work performed: replaced f17 computer while retaining original hard drive due to issues with pulling logs.All required testing was done.Found no more issues with robot.Robot is ready for clinical use.Work order disposition: system investigation completed successfully as per service manual.All system checks and tests passed, system is ready for use.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of device history records shows that (b)(6) was inspected and the quality inspection procedures were completed with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the alleged failure mode was confirmed.Successfully completed all checks, verifications, and calibrations.System is ready for clinical use.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
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Search Alerts/Recalls
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