Catalog Number ES2916 |
Device Problems
Fracture (1260); Inflation Problem (1310); Failure to Pump (1502)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/13/2023 |
Event Type
Injury
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Event Description
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According to the available information the device was explanted and replaced due to the pump not inflating.
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Manufacturer Narrative
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The lot number was reviewed for complaint trend, non-conforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed to be associated.
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Event Description
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Additional information received on 11/28/2023, states that re-surgery has taken place and it was observed that the connection tubing between the pump and cylinder is broken/fractured.
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Manufacturer Narrative
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The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed to be associated.
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Search Alerts/Recalls
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