Model Number EG16-K10 |
Device Problems
Partial Blockage (1065); Collapse (1099); Failure to Disconnect (2541)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/19/2022 |
Event Type
malfunction
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Manufacturer Narrative
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This device is not distributed in the usa, therefore the pma/510(k) number is not applicable.If additional information becomes available, a supplemental report will be filed with the new information.
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Event Description
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A brush stuck in the op-channel this event occurred at the time of during reprocessing.There was no report of patient harm.
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Manufacturer Narrative
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Correction information g6: follow up #1 h2:if follow-up, what type? h3:device evaluated by manufacture h6: coding changed based on the investigation result additional information h4:device manufacture date.Evaluation summary due to a stuck cleaning brush due to using an incompatible cleaning brush.
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Search Alerts/Recalls
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