COOK INC NCIRCLE 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 01/25/2024 |
Event Type
malfunction
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Event Description
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As reported, during a transurethral lithotomy (tul) procedure to remove a stone from urinary duct, an ncircle tipless stone extractor's basket did not function properly.The issue was noticed during the procedure when the basket did not return into the sheath, and the physician reported that the handle was hard to operate.It was mentioned the device separated, however, it is not known what on the device was separated.The device functioned properly when tested prior to use an uncoiled position.Another same time 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 additional procedures or 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 - name and address: phone: (b)(6), postal code: (b)(6).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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