Model Number 209063 |
Device Problem
Intermittent Loss of Power (4016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/12/2022 |
Event Type
malfunction
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Event Description
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The handpiece would not complete registration.All measures were tried to remedy the situation.Case type / application: tka.
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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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Manufacturer Narrative
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An event regarding registration fails involving a mako mics was reported.The event was not confirmed.Method & results product evaluation and results: handpiece mics ¿ 209063-r ¿ serial# (b)(6).Inspected and unable to determine original complaint.Original description not confirmed.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there are other complaints with a similar failure mode for this lot.Conclusions: the alleged failure mode was not confirmed.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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The handpiece would not complete registration.All measures were tried to remedy the situation.Case type / application: tka.
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Search Alerts/Recalls
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