Model Number OF-B206 |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/15/2021 |
Event Type
malfunction
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Event Description
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Pentax medical was made aware of an event which occurred in the pai region involving pentax accessories suction valves been very sticky.In the event reported, it was stated the suction valves have been very "sticky", and that it is impacting his procedures.He finds that he is having to remove them each time during procedures and dip them in water to have them not be stuck in a "down" position.There was no adverse event reported with this complaint.No other information provided with this complaint.
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Manufacturer Narrative
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This device is classified as import for export, therefore 510k is not applicable.The manufacture reviewed the complaint and notified the user that condition like this complaint case occur when silicon oil is not properly applied to the valves.Dhr cannot be performed since a lot nnumber was not provided.If additional information becomes available, a supplemental report will be filed with the new information.
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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.G4:premarket identification pma/510(k): model of-b206 is a suction valve, so there is no 510k number.Evaluation summary: although the cause was investigated, the reason why it could not be used could not be identified.The assumed cause is deterioration of the o-ring due to silicone oil.
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Search Alerts/Recalls
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