Model Number 209063 |
Device Problems
Loss of Power (1475); Complete Loss of Power (4015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/22/2021 |
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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Mako mics handpiece would not cut.Power to the handpiece but the saw would not oscillate and there was metal debris.New mics handpiece used.
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Manufacturer Narrative
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Reported event an event regarding non functional involving a mako mics was reported.The event was confirmed.Method & results product evaluation and results: handpiece mics ¿ 209063 ¿ serial# (b)(6) - rma#331104 inspected and determined failure of the following test steps: 7.1.5.1 original cable agitation test 7.1.5.3.4 tn 0835 cable functional (new cable) original description confirmed.Disposition: rtv - motor failure inspected by: spencer barfield clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices, including serial number (b)(6), were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there has been 1 other similar event for the lot referenced.Conclusions: the alleged failure mode was 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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Mako mics handpiece would not cut.Power to the handpiece but the saw would not oscillate and there was metal debris.New mics handpiece used.
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Search Alerts/Recalls
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