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Catalog Number NGE-022115 |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2024 |
Event Type
malfunction
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Event Description
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As reported, prior to an unknown procedure, the basket of the ngage nitinol stone extractor was tested and could not close.The procedure was complete with another same-like device.The patient did not experience any adverse effects due to the occurrence.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown or unavailable.G4: pma/510(k) number = exempt h3: device evaluated by mfg = other (81) -device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Search Alerts/Recalls
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