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	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 ¿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 a ureteral stone surgery in the urinary system, the user attempted to utilize the basket of an nforce nitinol helical stone extractor to remove ureteral calculi.The user advanced the device into the endoscope working channel to capture the stone and the basket would not open (refence this report).The user then changed to another same device reference (patient identifier (b)(6)) and the basket would not open.The user changed to a third same device to continue the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation evaluation it was reported, during a ureteral stone surgery in the urinary system, the user attempted to utilize the basket of an 'nforce nitinol helical stone extractor' to remove ureteral calculi.The user advanced the device into the endoscope working channel to capture the stone and the basket would not open (refence this report).The user then changed to another same device reference (patient identifier (b)(6) and the basket would not open.The user changed to a third same device to continue the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, manufacturing instructions (mi), instructions for use (ifu) and a functional test of the returned device, were conducted during the investigation.One 'nforce nitinol helical stone extractor' was returned.The device was unable to actuate basket either by handle or manually.Device was returned with cannula exposed.The cannula and the distal tip both appear damaged.The basket would not function due to the basket sheath having separated from the blue strain relief.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.The product ifu, did not provide any information related to the reported issue.Based upon the available information and 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: 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: 22002807
• Report Number: 1820334-2025-00509
• Device Sequence Number: 9390552
• Product Code: FFL
• UDI-Device Identifier: 00827002179400
• UDI-Public: (01)00827002179400(17)271009(10)NS16286626
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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: G17940
• Device Catalogue Number: NFHSES-032115-3W-UDH
• Device Lot Number: NS16286626
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2024
• 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: Unknown