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

Model Number	G32701
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, during a stone extraction procedure, that the basket wire of a ncompass nitinol tipless stone extractor snapped.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.There were no adverse effects to the patient reported.
Additional Manufacturer Narrative
E1: phone: (b)(6) g4 - pma/510(k) #: exempt.H3 - device will not 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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation: event description: it was reported, during a stone extraction procedure, that the basket wire of a noncompass nitinol tipless stone extractor broke.The procedure was completed using another same type device.There were no adverse effects to the patient reported.Reviews of complaint history, device history record (dhr), the instructions for use (ifu), and quality control procedures were conducted during the investigation.The complaint device was not returned.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 for the reported complaint device lot found no non-conformances.A review of complaint history records shows no other complaints associated with the complaint device lot.Based on the available information, cook has concluded that the device was manufactured to specification and there is no evidence suggesting nonconforming product exists either in house or in the field.The instructions for use (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.A cause for the broken basket wire could not be established.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified, and we will continue to monitor for similar complaints.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
Additional information was received 28oct2025: as reported, the procedure was completed using another same type device.

• Brand Name: NCOMPASS NITINOL 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: 22095902
• Report Number: 1820334-2025-00604
• Device Sequence Number: 7866850
• Product Code: FFL
• UDI-Device Identifier: 00827002327016
• UDI-Public: (01)00827002327016(17)270401(10)15983776
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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: G32701
• Device Catalogue Number: NCT4-024115
• Device Lot Number: 15983776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2024
• 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
• Patient Sex: Male
• Patient Weight: 55 KG