Catalog Number 209999 |
Device Problems
Device Difficult to Setup or Prepare (1487); Mechanical Jam (2983)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 10/08/2019 |
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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Robot would not pass verification phase.Case type: tka.Surgical delay: yes > 30 minutes.Patient under anesthesia.
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Event Description
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Robot would not pass verification phase.Case type: tka.Surgical delay: yes > 30 minutes.Patient under anesthesia.
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Manufacturer Narrative
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Robot would not pass verification phase.Device evaluation and results: per (b)(4): auto arm accuracy failed during presurgery on right side.Performed kin cal on right side.System investigation completed successfully as per service manual.All system checks and tests passed.Product history review: a review of device history records shows that on 03/02/17 1 device was inspected and 1 device was placed on: qt 17-02-0073.A review of the data revealed that the non-conformances are not related to the failure alleged in this compliant.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209999 shows no additional complaints related to the failure in this investigation.Conclusions: system ready for clinical use.
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Search Alerts/Recalls
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