Model Number 209999 |
Device Problems
Unintended System Motion (1430); Inappropriate Tactile Prompt/Feedback (4023)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/03/2022 |
Event Type
malfunction
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Event Description
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Mps reported arm dropping upon entering haptics.
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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.Not available.
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Manufacturer Narrative
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Reported event: an event regarding incorrect gravity compensation 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: mics gravity was off.Work performed: calibrated left and right side arm.Ran mics gravity test.Arm held position in mics gravity after gravity test.Cleaned hydraulic fluid from reservoir and below the mako.Completed all required post repair testing.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: a review of complaints shows 0 additional complaints related to the failure in this investigation.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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Event Description
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Mps reported arm dropping upon entering haptics.
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Search Alerts/Recalls
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