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Model Number 209999 |
Device Problems
Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/23/2019 |
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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Case number: (b)(4) - mps (b)(6) reported angle discrepancy failure in j5.Surgery was not completed robotically.Update: case type: tka.Any surgical delay? (no delay, < 15 min, < 30 min, = 30 min): yes <30 min.Was the case cancelled? (yes/no) no.Was procedure completed successfully? (yes/no) yes.Was procedure completed manually? (yes/no ¿ explain) yes, robotic failure.Occurred during intra-op rio registration.Bone registration and joint balancing were complete, but no resections were made with the rio.Was the patient under anesthesia at the time of the issue? (yes/no) yes.
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Manufacturer Narrative
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Mps reported angle discrepancy failure in j5.Surgery was not completed robotically.Device evaluation and results: per (b)(4): error was on j6 not j5.Cleaned j6 encoder, kin-cal both sides.Verified robot no longer has error.Completed all testing and verifications.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 06/26/2012 1 device was inspected and 1 device was placed on: npr 12-05-0098, npr 12-05-0038.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 201903 shows no additional complaints related to the failure in this investigation.Conclusions: system ready for clinical use.
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Event Description
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Case number: (b)(4).Reported angle discrepancy failure in j5.Surgery was not completed robotically.Update: case type: tka.Any surgical delay? (no delay, < 15 min, < 30 min, = 30 min): yes <30 min.Was the case cancelled? (yes/no) no.Was procedure completed successfully? (yes/no) yes.Was procedure completed manually? (yes/no ¿ explain).Yes, robotic failure occurred during intra-op rio.Registration.Bone registration and joint balancing were complete, but no resections were made with the rio.Was the patient under anesthesia at the time of the issue? (yes/no) yes.
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Search Alerts/Recalls
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