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

Model Number	G19110
Medical Device Problem Codes	Break (1069); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A5 - ethnicity= chinese, e1 - customer email= (b)(6), g4 ¿ pma/510(k) #: exempt, h3 - device has not yet been returned to manufacturer; however, our investigation is ongoing, and device evaluation summary will be included in our follow up report once our investigation has been completed.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 delta wire tipless stone extractor¿s basket wire broke while removing a stone during a retrograde intrarenal surgery (rirs) procedure in the left kidney.No part of the device remained in the patient.The procedure was completed by using another same-like device.The device was tested prior to use.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
Investigation evaluation description of event: it was reported the ncircle delta wire tipless stone extractor¿s basket wire broke while removing a stone during a retrograde intrarenal surgery (rirs) procedure in the left kidney.No part of the device remained in the patient.The procedure was completed by using another same-like device.The device was tested prior to use.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, as well as a visual inspection and functional test of the returned device, were conducted during the investigation.One ncircle delta wire tipless stone extractor was returned in an open package with label.Basket wires were broken, one near the distal tip and one near the shaft.Both breaks show signs of charring.The handle will actuate the basket.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 review of complaint history records shows no other related complaints associated with device lot.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that that the device was manufactured to specification and there is no evidence that nonconforming product exists in house or in the field.Cook also reviewed product labeling.The product ifu, provides the following information to the user: precautions · the device is conductive.Avoid contact with any electrified instrument.· enclose the device in the sheath before removing from the tray/holder.· do not use excessive force to manipulate this device.Damage to the device may occur.How supplied upon removal from the package, inspect the product to ensure no damage has occurred.Based on the information provided, inspection of the returned device, and the results of the investigation, unintended use error caused or contributed to the event.The broken ends of the wires had evidence of charring, indicating exposure to a laser or other electrified device.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 DELTA WIRE 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: 21604713
• Report Number: 1820334-2025-00262
• Device Sequence Number: 13128388
• Product Code: FFL
• UDI-Device Identifier: 00827002191105
• UDI-Public: (01)00827002191105(17)270910(10)16243393
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

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 Model Number: G19110
• Device Catalogue Number: NTSED-024115-UDH
• Device Lot Number: 16243393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2024
• 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: ANQING SOFT ENDOSCOPE.; BOSTON SCIENTIFIC WIRE GUIDE.; COOK SHEATH.
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 60 KG