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

Model Number	G46206
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the basket of an ncircle tipless stone extractor experienced a sense of ¿heaviness¿ in the handle during a transurethral urinary stone removal procedure within the renal pelvis and calyces.The use of the device was discontinued immediately, and the procedure was completed using another ncircle tipless stone extractor from the hospital¿s inventory while the patient was under anesthesia.The patient did not require a separate procedure.The device was able to capture several stones before the occurrence.The device was inspected prior to use in an uncoiled position and functioned properly.Another manufacturers 3.6 fr size scope was used with the device; however, no laser was used.There were no anatomical factors impeding device function.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
E1: postal code: (b)(6), phone: (b)(6).G4 - pma/510(k)# exempt.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 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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation as reported, the basket of an ncircle tipless stone extractor experienced a sense of ¿heaviness¿ in the handle during a transurethral urinary stone removal procedure within the renal pelvis and calyces.The use of the device was discontinued immediately, and the procedure was completed using another ncircle tipless stone extractor from the hospital¿s inventory while the patient was under anesthesia.The patient did not require a separate procedure.The device was able to capture several stones before the occurrence.The device was inspected prior to use in an uncoiled position and functioned properly.Another manufacturer 3.6 fr size scope was used with the device; however, no laser was used.There were no anatomical factors impeding device function.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, specifications and instructions for use (ifu), as well as a visual inspection and functional test of the returned device, were conducted during the investigation.One ncircle tipless stone extractor was returned to cook without package, but with label.Upon visual inspection, it was noted that several bends/kinks were found along the basket sheath.The handle was actuated and the basket was very difficult to open/close.The basket wire broke.Additional damage may have occurred during shipment, as the product was not returned in its original packaging.Cook has concluded that the device was manufactured to specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record showed no discrepancies related to the reported failure mode.A review of complaint history records showed no other related complaints associated with the complaint device lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling.The ifu was reviewed and did not contain any information related to the reported issue.Based on the information provided, inspection of the returned device, and the results of the investigation.Cook has concluded a potential root cause for this event could not be established.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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.

• 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: 24675162
• Report Number: 1820334-2026-00314
• Device Sequence Number: 10108836
• Product Code: FFL
• Combination Product (Y/N): N
• 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: Other,Foreign,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2026

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: G46206
• Device Catalogue Number: NTSE-015115
• Device Lot Number: 16850164
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/02/2026
• 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: 03/13/2026
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2025
• 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: 3.6FR KARL STORZ / FLEX-X2 SCOPE.
• Patient Sex: Unknown