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Catalog Number NGE-017115 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/11/2024 |
Event Type
malfunction
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Event Description
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As reported, prior to a stone removal procedure, an ngage nitinol stone extractor's handle separated from the device while being tested.Another device of the same type was used to complete the procedure.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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E1: line 2: (b)(6), additional phone: (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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