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

Model Number	G32862
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the distributor that foreign matter was found in an unopened 'perc circle nitinol tipless stone extractor' package.There was no patient involvement.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.G4 ¿ pma/510(k) #: exempt.H3: device evaluation is 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
Investigation ¿ evaluation: it was reported by the distributor that foreign matter (yellowish-brown discoloration spots) was found in an unopened 'perc ncircle nitinol tipless stone extractor' package.There was no patient involvement.Reviews of the complaint history, device history record (dhr), manufacturer¿s instructions (mi), and quality control (qc) procedures were conducted during the investigation.Visual inspection of the returned complaint device was also conducted.One device was returned for investigation visual exam notes yellowish brown discoloration is noted on the tyvek portion of the sealed pouch.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 tree related non-conformance's reported for lot.One device was scrapped for foreign matter.The nonconformance was not sufficient evidence to conclude other devices in the lot were nonconforming.A complaint history database search showed no other complaint related to this failure mode (discoloration).Because there is 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.Based upon the available information, inspection of the returned device, and results of the investigation, cook has concluded that the cause for the complaint 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.
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: PERC NCIRCLE 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: 22036675
• Report Number: 1820334-2025-00557
• Device Sequence Number: 8260876
• Product Code: FFL
• UDI-Device Identifier: 00827002328624
• UDI-Public: (01)00827002328624(17)270816(10)16209976
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 11/24/2025

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
• Device Model Number: G32862
• Device Catalogue Number: NTRSE-100038
• Device Lot Number: 16209976
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown