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Model Number 209063 |
Device Problems
Electrical /Electronic Property Problem (1198); Output Problem (3005)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/11/2019 |
Event Type
malfunction
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Manufacturer Narrative
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As part of the 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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Mics status check passed, and rio setup and registration was fine.Once case started, at time of bone prep starting with saw, the trigger would not align the robot arm.We changed to the burr and same result.Cutter reset same result.Warning of "cable connection error in cutting system" was displaying.We opened a backup mics with the same result.I then did mics status check and that failed.We then used a backup rio system to rule it out.We opened a 3rd mics for the new system and completed the case successfully.After the case the original mako system 118 was rebooted, the mics duplicated the communication warning and mics status check failed.The 2nd mics tested fine with rob118 so the 1st mics was tagged bad.Case type: pka (mics).Surgical delay: =15 minutes.
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Event Description
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Mics status check passed, and rio setup and registration was fine.Once case started, at time of bone prep starting with saw, the trigger would not align the robot arm.We changed to the burr and same result.Cutter reset same result.Warning of "cable connection error in cutting system" was displaying.We opened a backup mics with the same result.I then did mics status check and that failed.We then used a backup rio system to rule it out.We opened a 3rd mics for the new system and completed the case successfully.After the case the original mako system 118 was rebooted, the mics duplicated the communication warning and mics status check failed.The 2nd mics tested fine with rob118 so the 1st mics was tagged bad.Case type: pka (mics) surgical delay: =15 minutes.
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Manufacturer Narrative
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Mics status check passed, and rio setup and registration was fine.Once case started, at time of bone prep starting with saw, the trigger would not align the robot arm.We changed to the burr and same result.Cutter reset same result.Warning of ""cable connection error in cutting system"" was displaying.We opened a backup mics with the same result.I then did mics status check and that failed.We then used a backup rio system to rule it out.We opened a 3rd mics for the new system and completed the case successfully.After the case the original mako system 118 was rebooted, the mics duplicated the communication warning and mics status check failed.The 2nd mics tested fine with rob118 so the 1st mics was tagged bad.Case type: pka (mics).Surgical delay: =15 minutes.Product inspection: mics-209063, sn#: (b)(6), rma#280111, lot 42020316.Inspected per d06917 and determined failure of the following test step.Sec# 7.1.2.Visual no power with new cable.Disposition: rtv device history review: review of device history records indicate (b)(4) devices were manufactured under lot k076w and all were accepted into final stock on 04/14/2016 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209063, lot number 42020316 shows 2 additional complaints related to the failure in this investigation.Conclusion: the alleged failure mode was confirmed.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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