Model Number 219999 |
Device Problems
Positioning Failure (1158); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/09/2021 |
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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Could not get femur to pass registration.Lateral side was deep and medial side was proud.Actions: verified correct patient and side.Cleared all landmarks and retook (several times) reset landmarks checked segmentation check visidisc changed probe changed array hard shut down and restart reset arm software checked camera for cleanliness tourniquet time was extended due to issues and case was completed with navigation.Surgical delay: > 30 minutes.Surgery was completed manually.Case type / application: tka.
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Manufacturer Narrative
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An event regarding registration fails involving a mako tka software was reported.The event was not confirmed because the product was not available for inspection.Method & results -product evaluation and results: product inspection could not be performed as the product was not made available for evaluation within 60 days of the complaint being opened.The complaint will be closed with an associated risk assessment.Additional failures will be assessed once the product becomes available.-clinician review: no medical records were received for review with a clinical consultant.-product history review: a review of device history records shows that rob1090 was inspected 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: rob1090 shows 0 similar complaints for tka software - registration fails.Conclusions: the exact cause of the event could not be determined because insufficient information was made available for evaluation.Review of the log/session files has not been completed within 60days of the complaint being opened.A review of the case session/log data is needed to complete a full investigation for determining root cause.In addition to a review of the log/session, a field service engineer conducts scheduled maintenance on the robot to ensure the robot is system ready.Once the review of the log/session files has been completed then the complaints team will reopen and re-evaluate the complaint.Product surveillance will continue to monitor for trends.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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Could not get femur to pass registration.Lateral side was deep and medial side was proud.Actions: verified correct patient and side cleared all landmarks and retook (several times) reset landmarks checked segmentation check visidisc changed probe changed array hard shut down and restart reset arm software checked camera for cleanliness tourniquet time was extended due to issues and case was completed with navigation.Surgical delay: > 30 minutes.Surgery was completed manually.Case type / application: tka.
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Search Alerts/Recalls
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