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Catalog Number NGE-017115 |
Device Problems
Break (1069); 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 01/25/2024 |
Event Type
malfunction
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Event Description
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As reported, the ngage nitinol stone extractor's basket was unable to open and close during a flexible ureterolithotomy procedure.Another same-like device was used to complete the procedure.It was stated that it was noticed "the tip failed to shrink and the front end fractured".The device was returned and the preliminary analysis found a wire had separated in the basket assembly.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Manufacturer Narrative
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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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