COOK INC NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL
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Model Number N/A |
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 01/19/2024 |
Event Type
malfunction
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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)#: exempt.This report includes information known at this time.A followup 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 or that a death or serious injury occurred; nor is it admission 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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Event Description
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As reported, during an ureteroscopy procedure, an ncircle delta wire tipless stone extractor's basket did not close to its full potential.The basket was tested prior to use, and it was unable to fully close.The basket was then used to retrieve a stone and would not close around the stone.Another same type device was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any other additional intervention or experience any adverse effects due to this occurrence.
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Search Alerts/Recalls
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