Model Number 209063 |
Device Problems
Positioning Failure (1158); Separation Failure (2547); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/08/2021 |
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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Mic is really loud with flat saw.Cuts were proud and a mallet is needed to get attachments out.Black residue building up on the outside of the mics.Surgical delay = 15 minutes.Case type / application: tka.
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Event Description
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Mic is really loud with flat saw.Cuts were proud and a mallet is needed to get attachments out.Black residue building up on the outside of the mics.Surgical delay = 15 minutes.Case type / application: tka.
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Manufacturer Narrative
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Reported event: an event regarding noise involving a mako mics was reported.The event was not confirmed because the product was not available for inspection.Method & results: product evaluation and results: product inspection could not be performed as the product was not made available for evaluation within 60 days of the complaint being opened.The complaint will be closed with an associated risk assessment.Additional failures will be assessed once the product becomes available for inspection.-clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate (b)(4) devices, including serial number (b)(6), were manufactured and accepted into final stock on 05/01/2020 with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the alleged failure mode was not confirmed because the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
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Search Alerts/Recalls
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