Model Number 100145CO2EXT |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/30/2022 |
Event Type
malfunction
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Event Description
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The user facility reported that the pinch clamp for their endo smartcap tubing is not staying closed allowing water to leak onto the floor.No report of injury.
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Manufacturer Narrative
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The investigation into the reported event is in process; a follow-up report will be submitted when additional information becomes available.
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Manufacturer Narrative
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Investigation determined that the cause of the tubing not staying clamped was attributed to the tip (point) of the clip.The tip is seated within the "teeth" of the clip to keep the clip engaged/closed.As the tip was not sharp/pointy enough, this allowed the point to detach from the teeth resulting in the reported issue.The issue appears to be isolated to a very small number of clips.We have notified our supplier, and will continue to monitor post-market data for trends.
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Search Alerts/Recalls
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