Model Number 219999 |
Device Problem
Separation Problem (4043)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/05/2021 |
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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Case number: (b)(4): mps (b)(6) reported arm shaking/vibrating abnormally during posterior chamfer cuts.This issue occurred in a case last week and again today (b)(6) 2021.When the arm was shaking/vibrating, the mics never lost power nor were there any error messages on the screen related to patient positioning relative to the robot.Surgery was not completed robotically.
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Event Description
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Case number: (b)(4): mps erin gill reported arm shaking/vibrating abnormally during posterior chamfer cuts.This issue occurred in a case last week and again today ((b)(6) 2021).When the arm was shaking/vibrating, the mics never lost power nor were there any error messages on the screen related to patient positioning relative to the robot.Surgery was not completed robotically.
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Manufacturer Narrative
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Reported event: 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: none.Work performed: adjusted j5 transmission cable to nominal value.Verified all joints are within nominal range of tension.Cleaned camera lenses.All required testing has passing results.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 rob1111 was inspected on 27/02/2020 and the quality inspection procedures were completed with no reported discrepancies complaint history review: a review of complaints in trackwise related to p/n 219999, robot number: rob1111 shows 0 additional complaints related to the failure in this investigation.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.
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Search Alerts/Recalls
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