Catalog Number 209999 |
Device Problems
Mechanical Problem (1384); Device Displays Incorrect Message (2591)
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Patient Problems
Discomfort (2330); No Known Impact Or Consequence To Patient (2692)
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Event Date 01/24/2017 |
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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The surgeon was about to begin a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio), when the system displayed a hall error during arm status check.The patient was already under anesthesia when the surgeon decided to cancel the case.
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Manufacturer Narrative
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Based on the results of investigation.Reported device: the reported device is a motor assy, j3, catalog # 207569, lot # rob401, rma# (b)(4).Device history review: the device history shows that the system that includes this component was manufactured and accepted into final stock on 1/28/2016.Device evaluation and results: gsp case (b)(4) states that the j3 hall error was confirmed.The motor assembly was replaced to correct the issue.Complaint history review: a review of complaints related to system rob401 related to the failure in this investigation shows one additional complaint: (b)(4).Conclusions: the system produced a hall error.The motor was replaced, which fixed the issue.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.
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Event Description
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The surgeon was about to begin a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio), when the system displayed a hall error during arm status check.The patient was already under anesthesia when the surgeon decided to cancel the case.
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Search Alerts/Recalls
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