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

Model Number	G18777
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - country: south korea g4 ¿ pma/510(k) #: exempt h3 - device not returned to manufacturer.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 the ncircle tipless stone extractor¿s wire appeared to be out of the basket prior to patient contact during an unspecified procedure.A supplied photo appeared to show the handle and sheath of the device was not being held in place in the clear shipping tray.The pouch was sealed.No additional photos are available.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Corrected information: h6: component code (annex g)- g04094 packaging.Investigation evaluation.Description of event: it was reported the ncircle tipless stone extractor¿s wire appeared to be out of the basket prior to patient contact during an unspecified procedure.A supplied photo appeared to show the handle and sheath of the device was not being held in place in the clear shipping tray.The pouch was sealed.No additional photos are available.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi), and quality control (qc) procedures, were conducted during the investigation.The complaint device was not returned.A picture was supplied by the customer that showed the handle of the device was not being held properly in the shipping tray.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 (dhr) found no non-conformances related to the reported failure mode.A lot history search found no other complaints had been reported for this 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 has concluded that the device was manufactured to specification.The product ifu, provides the following information to the user: how supplied upon removal from the package, inspect the product to ensure no damage has occurred.Based on the information provided, no product returned, and the results of the investigation, cook has concluded that the cause for the complaint could not be established.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering 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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN ; 8123392235
• MDR Report Key: 21349166
• Report Number: 1820334-2025-00124
• Device Sequence Number: 12752370
• Product Code: FFL
• UDI-Device Identifier: 00827002187771
• UDI-Public: (01)00827002187771(17)250425(10)NS14685964
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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 Expiration Date: 04/22/2025
• Device Model Number: G18777
• Device Catalogue Number: NTSE-022115-UDH-MB
• Device Lot Number: NS14685964
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2022
• 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
• Patient Sex: Unknown