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

Model Number	G17940
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1- occupation: quality specialist.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.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 the basket of an nforce nitinol helical stone extractor was not opening.The user replaced the product to complete the procedure.No unintended section of this device remain inside the patient¿s body.The patient was not hospitalized and did not undergo prolonged hospitalization due to this occurrence.The patient did not experience a delay or require any additional procedure due to this occurrence.The complainant did not report any adverse effects on the patient due to this occurrence.
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
Correction: d8 investigation ¿ evaluation it was reported, during an unspecified procedure the basket of an nforce nitinol helical stone extractor was not opening.The user replaced the product to complete the procedure.No unintended section of this device remains inside the patient¿s body.The patient was not hospitalized and did not undergo prolonged hospitalization due to this occurrence.The patient did not experience a delay or require any additional procedure due to this occurrence.The complainant did not report any adverse effects on the patient due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturer¿s instructions (mi), and quality control (qc) procedures were conducted during the investigation.Functional tests and visual inspection of the returned complaint device was also conducted.The complaint device was returned to cook for investigation in the packaging tray from the opened original packaging.The device handle moves freely on the basket assembly and does not actuate basket formation.The handle was disassembled and does not manually actuate.The support sheath is loose from basket sheath.Evidence of adhesive on basket sheath is present.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 related non-conformances reported to this incident.A complaint history database search showed no other related complaints associated with the failure mode for the complaint 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, cook has concluded that the device was manufactured to specification and that there is no evidence that nonconforming product exists in house or in field.Cook also reviewed product labeling; the ifu supplied with the device states the following in consideration of the reported failure mode: intended use: the ncircie, ncompass, and nforce stone extractors are intended for stone manipulation and removal in the urinary tract.Precautions: do not use excessive force to manipulate this device.Damage to the device may occur.Based upon the available information, inspection of the returned device, and results of the investigation, cook has concluded that the cause could not be established.The returned device was found to have a basket that was closed and could not be opened due to separation of the blue support sheath from the amber basket sheath.Evidence of adhesive was observed on the basket sheath, indicating proper manufacturing.The cause for the separation of the two sheaths 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: NFORCE NITINOL HELICAL 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: 22168822
• Report Number: 1820334-2025-00672
• Device Sequence Number: 7957511
• Product Code: FFL
• UDI-Device Identifier: 00827002179400
• UDI-Public: (01)00827002179400(17)260622(10)15502386
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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 Expiration Date: 06/22/2026
• Device Model Number: G17940
• Device Catalogue Number: NFHSES-032115-3W-UDH
• Device Lot Number: 15502386
• 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: 05/21/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2023
• 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: Female