Model Number 209999 |
Device Problem
Unintended System Motion (1430)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/01/2022 |
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 arm dropping out of haptics after motorized alignment.Case completed robotically.
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Event Description
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Mps reported arm dropping out of haptics after motorized alignment.Case completed robotically.
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Manufacturer Narrative
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An event regarding unintended movement involving a mako robotic arm was reported.The event was not confirmed.Method & results: product evaluation and results: the field service engineer reported: problem reproduced? no.Trouble shooting notes: (b)(6) - mps reported arm dropping out of haptics after motorized alignment.Work performed: set up the system and do a successful pre surgery check.Check right and left accuracy - all tests have been nominal.Right side of the robot shown medium numbers of accuracy - new calibrated with great numbers.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: review of the device history records indicate that devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the alleged failure mode was not 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.H3 other text : not returned.
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Search Alerts/Recalls
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