Catalog Number 209999 |
Device Problems
Electrical /Electronic Property Problem (1198); Device Displays Incorrect Message (2591)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/23/2016 |
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 completing a total hip arthroplasty procedure using the robotic arm interactive orthopedic system (rio), when the robotic arm froze while reaming, reporting a hardware error and a hall error.
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Manufacturer Narrative
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Device identification: the returned device was confirmed to be a cable assy, hall effect j5, catalog #: 201405, serial #: (b)(4).Device history review: a review of the dhr associated with rio 417 found quality inspection procedures successfully passed.Device evaluation and results: per gsp case# (b)(4), the fse confirmed j5 hall errors in the system lots.The j5 hall cable was replace, which fixed the issues.Complaint review: a review of complaints in catsweb and trackwise related to p/n 201405 shows no additional complaints related to the failure in this investigation.Conclusions: the failure mode was confirmed.The fse confirmed there were hall errors.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 completing a total hip arthroplasty procedure using the robotic arm interactive orthopedic system (rio), when the robotic arm froze while reaming, reporting a hardware error and a hall error.
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Search Alerts/Recalls
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