Model Number 209063 |
Device Problem
Residue After Decontamination (2325)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/22/2022 |
Event Type
malfunction
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Event Description
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Black residue found on mics handles and sawblade attachments, causing concerns regarding sterility.Surgeon requiring answers to what it is.All saw attachments replaced but issue persists, replacing hand pieces.No surgical delay.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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Event Description
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Black residue found on mics handles and sawblade attachments, causing concerns regarding sterility.Surgeon requiring answers to what it is.All saw attachments replaced but issue persists, replacing hand pieces.No surgical delay.Case type / application: tka.
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Manufacturer Narrative
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Reported event an event regarding foreign matter involving a mako mics was reported.The event was not confirmed.Method & results: -product evaluation and results: handpiece mics ¿ 209063 ¿ serial#(b)(6).Inspected and determined failure of the following test steps: 7.1.1 cable visual inspection - pass.7.1.2 hand piece visual inspection - pass.7.1.3 pivot handle lock test - pass.7.1.4 collar test - pass.7.1.5.1 original cable agitation test - pass.7.1.5.3.4 tn 0835 cable functional (new cable) - n/a.Original description not confirmed.Disposition: rtv.-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 no 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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Search Alerts/Recalls
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