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

Model Number	G32701
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: phone = (b)(6).G4: pma/510(k) = exempt h3: device evaluated by mfg = 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
As reported, during an unspecified procedure, the basket of 'ncompass nitinol tipless stone extractor' could not be opened.The issue was discovered after removing the outer packaging; hence the product could not be used.The procedure was completed successfully using another new device.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures or experience any adverse effects due to this event.

• 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: 23352210
• Report Number: 1820334-2025-01274
• Device Sequence Number: 9131077
• Product Code: FFL
• UDI-Device Identifier: 00827002327016
• UDI-Public: (01)00827002327016(17)280224(10)16480202
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/21/2025

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: 16480202
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2025
• 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