MAUDE Adverse Event Report: COOK INC. NCIRCLE TIPLESS STONE EXTRACTOR; FFL, DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	G18778
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: first name: unknown g4 - pma/510(k) #: exempt h3: it is unknown if the device is going to be returned.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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
It was reported, during an unspecified procedure, two ncircle tipless stone extractors (reference this report) failed to fully close while the surgeon was extracting stones from a patient´s kidney.The surgeon then changed to a third same device, of a different lot, (reference patient identifier (b)(6) and the third one also failed.The surgeon then opened an equivalent device from a different manufacturer to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Additional information has been requested, however, at the time of this report, no further information has been provided.
Event or Problem Description
Additional information was received 30jan2026: the procedure being performed was a ureteroscopy.The open and close function of the device was tested prior to use.Tortuous, calcified, or scarred patient anatomy was denied.
Additional Manufacturer Narrative
Additional information: b5, d9, e4.H3 - device evaluation anticipated but not yet begun.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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: NCIRCLE TIPLESS STONE EXTRACTOR
• Common Device Name: FFL, DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 23832135
• Report Number: 1820334-2025-01571
• Device Sequence Number: 9288259
• Product Code: FFL
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G18778
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: 16795703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 01/30/2026; 08/11/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/24/2026; 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC EQUIVALENT PRODUCT
• Patient Sex: Unknown