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Catalog Number NGE-017115 |
Device Problems
Detachment of Device or Device Component (2907); 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 04/03/2024 |
Event Type
malfunction
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Event Description
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As reported, the ngage nitinol stone extractor would not close prior to a billateral ureteroscopy.When the device was tested, the user found "presence of a thread" which prevented the device from closing.The procedure was complete by using another same-like device.The device did not make patient contact.The patient did not require any additional intervention and did not experience any adverse effects due to this occurrence.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown or unavailable.E1: customer name and address = (b)(6).G4: pma/510(k) number = exempt.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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