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

Model Number	G32701
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, during an unspecified kidney procedure, the ncompass nitinol tipless stone extractor's basket was unable to function.A customer provided video appears to show the basket did not push out to open when the handle was activated.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 information was requested.
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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Additional information: b5, d9 h3: device evaluated by mfg = device evaluation has begun; however, a conclusion is not yet available.Correction: d4 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
Additional information was received 25feb2026.The procedure was completed by using an unspecified new device.
Additional Manufacturer Narrative
Summary of event: it was reported, during an unspecified kidney procedure, the ncompass nitinol tipless stone extractor's basket was unable to function.A customer provided video appears to show the basket did not push out to open when the handle was activated.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 information was received on 25feb2026.The procedure was completed by using an unspecified new device.Investigation evaluation: reviews of the complaint history, device history record (dhr), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection and functional test of the complaint device were also conducted.The complaint device was returned to cook for investigation.The handle does not actuate the basket formation.A visual exam noted the basket sheath is smashed/kinked 13 mm from distal tip.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 found that two devices from the lot did not pass quality control inspections; however, the affected products were scrapped prior to release from cook.A lot history search found no other complaints had been reported for this lot.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling.The ifu packaged with the device does not contain information relevant to the reported event.Based on the information provided and the results of the investigation, a definitive cause of the device damage could not be determined.The risk analysis for this failure mode was reviewed, and no additional escalation was required.The appropriate personnel have been notified, and cook will continue to monitor for similar events.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: 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: 22821732
• Report Number: 1820334-2025-01001
• Device Sequence Number: 18579479
• Product Code: FFL
• UDI-Device Identifier: 00827002327016
• UDI-Public: (01)00827002327016(17)271015(10)16296293
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2026

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 Model Number: G32701
• Device Catalogue Number: NCT4-024115
• Device Lot Number: 16296293
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 02/25/2026; 03/30/2026
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 03/03/2026; 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2024
• 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: 56 KG