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	02/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1- title: purchasing executive g4 - pma/510(k) #: exempt h3 - device evaluation anticipated, but not yet begun h8 - usage of device: not used.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 by the distributor, the perc ncircle nitinol tipless stone extractor has some white bubbles inside the packaging.The device was stored in distributor´s warehouse, the storage conditions are regulated by nom-241-ssa1-2012, at 52 humidity, 21celsius degrees.This observation was made prior to patient contact.The customer attached images of what appears to show foreign matter - white bubbles, inside the package.Patient was not involved.The complainant has not reported any adverse effects on the patient due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: h6: component code (annex g).Correction: e4.Investigation ¿ evaluation.Event description: it was reported by the distributor, the perc ncircle nitinol tipless stone extractor has some white bubbles inside the packaging.The device was stored in distributor´s warehouse, the storage conditions are regulated by nom-241-ssa1-2012, at 52 humidity, 21celsius degrees.This observation was made prior to patient contact.The customer attached images of what appears to show foreign matter - white bubbles, inside the package.Patient was not involved.The complainant has not reported any adverse effects on the patient due to this occurrence.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record (dhr), and quality control procedures.One perc ncircle nitinol tipless stone extractor was returned in an opened labelled package.White foreign matter was found in the sealed package.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 one non-conformance related to the reported failure mode.The non-conforming product was scrapped prior to lot release.The nonconformance was not sufficient evidence to conclude other devices in the lot were nonconforming.A review of complaint history records shows no other related complaints associated with the complaint device lot.Based on the available information, cook has concluded that the device was manufactured to specification and there is no evidence suggesting nonconforming product exists either in house or in the field.A few small white particles were observed on the handle of the device inside the unopened pouch.Based on the small size and number of particles, the device met the specifications of the particulate inspection criteria for all packaged product.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified, and we will continue to monitor for similar complaints.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.

• 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; IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 21505252
• Report Number: 1820334-2025-00204
• Device Sequence Number: 7962661
• Product Code: FFL
• UDI-Device Identifier: 00827002328624
• UDI-Public: (01)00827002328624(17)270816(10)16209976
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 08/19/2025

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): Initial
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 08/19/2025
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown