Catalog Number 209063 |
Device Problems
Mechanical Problem (1384); Output Problem (3005)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/23/2019 |
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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Mics hand piece unable to register to the robot, case converted to manual.Issue noticed pre-op.Surgical delay: 16-30 minutes.Case type: tka.Update: "yes patient was in the room at time of discovery.Yes patient was under anesthesia at time of discovery and delay.".
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Event Description
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Mics hand piece unable to register to the robot, case converted to manual.Issue noticed pre-op.Surgical delay: 16-30 minutes.Case type: tka.Update: "yes patient was in the room at time of discovery.Yes patient was under anesthesia at time of discovery and delay.".
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Manufacturer Narrative
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Follow-up #1 and final report submitted to update sections.Reported event: it was reported that mics hand piece unable to register to the robot, case converted to manual.Product evaluation and results: mics-209063, sn#: (b)(6), rma#: 273863.Inspected per d06917 and determined failure of the following test step.Sec#: 7.1.2.Visual sticky trigger.Disposition: rtv.Inspected by: (b)(6).Product history review: device history records indicate 25 devices were manufactured under lot: k0bpx and 23 devices were accepted into final stock on 08/27/2018.Review of qt18 - 08 - 0100 revealed that the non-conformance is not related to the failure alleged in this compliant.Complaint history review: a review of complaints in catsweb and trackwise related to p/n: 209063, prodex lot: k0bpx, shows no additional complaint(s) related to the failure in this investigation.Conclusions: the alleged failure mode was confirmed.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated that there have been no nc and capa are associated with the failure mode reported in this event.
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Search Alerts/Recalls
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