COOK INC NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL
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Model Number N/A |
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 01/26/2024 |
Event Type
malfunction
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Manufacturer Narrative
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E1 - name and address: (b)(6).E3 - occupation: agent.G4 - pma/510(k)#: 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 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, prior to use of an ncircle delta wire tipless stone extractor for an ureteral stone removal procedure, handle of the device was found broken upon opening the package.The basket did not open or close properly due to the broken handle.The device did not make patient contact and another same type device was used to complete the procedure.The patient did not require any additional procedures or experience any adverse effects due to this occurrence.
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Search Alerts/Recalls
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