MAUDE Adverse Event Report: COOK INC N-COMPASS NITINOL STONE EXTRACTOR; LQR DISLODGER, STONE, BILIARY

Model Number	G36251
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1 - customer (person): phone: (b)(6).H3 - device evaluated by mfg? device evaluation is anticipated but has 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 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 or that a death or serious injury occurred; nor is it admission 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
It was reported that upon opening two n-compass nitinol stone extractors it was discovered the baskets had a broken wire.The devices did not make patient contact.A new like device was used to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation: it was reported that upon opening two n-compass nitinol stone extractors it was discovered the baskets had a broken wire.The devices did not make patient contact.A new like device was used to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of the documentation including the complaint history, device history record, quality control procedures and instructions for use (ifu), as well as a visual examination of the of the returned devices, were completed during the investigation.Two products were returned for evaluation in open original packaging.The first basket formation/assembly could not be withdrawn from the product protector without further damage to the formation.Two of the four points where the wires come together into the basket sheath were broken.For the second device, the basket formation was separated from the assembly and had broken wires.The assembly body returned with the basket formation was in two pieces in a small clear box.The point of separation between the small piece and the rest of the formation had a charred, ragged appearance.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 quality control discrepancies.It should be noted that there were no other complaints associated with the final product lot number.Cook also reviewed product labeling.The product ifu, t _ ncnse_ rev2, provides the following information to the user: warnings: this device can conduct electrical current.Avoid contact with any electrified instrument.Evidence provided by a review of the complaint file, dhr, complaint history, and quality control documents did not provide evidence to support that the device was manufactured out of specification or to suggest items in the lot or similar devices in the field or in house were nonconforming.Based on the information provided, examination of the returned product, and the results of this investigation, a definitive cause for the failure could not be established.Per the risk assessment no further action is required.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.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 patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: N-COMPASS NITINOL STONE EXTRACTOR
• Common Device Name: LQR DISLODGER, STONE, BILIARY
• 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: 22371721
• Report Number: 1820334-2025-00802
• Device Sequence Number: 12766609
• Product Code: LQR
• UDI-Device Identifier: 00827002362512
• UDI-Public: (01)00827002362512(17)260912(10)15804419
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K173009
• 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): 01/30/2026

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: 09/12/2026
• Device Model Number: G36251
• Device Catalogue Number: C-NTSE-2.4-115-NCT4
• Device Lot Number: 15804419
• 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: 06/20/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2023
• 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: Unknown