MAUDE Adverse Event Report: COOK INC URODYNAMICS LOOP CATHETER; FAP CYSTOMETRIC GAS (CARBON0DIOXIDE) ON HYDRAULIC DEVICE

Model Number	G16705
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	10/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that foreign material was found inside the sterile packaging of a urodynamics loop catheter.An image was provided confirming foreign black material within the packaging.The foreign matter was found by the distributor, and the product was unused.There was no patient involvement.
Additional Manufacturer Narrative
E1: phone number: (b)(6).E3: occupation: quality analyst.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.

• Brand Name: URODYNAMICS LOOP CATHETER
• Common Device Name: FAP CYSTOMETRIC GAS (CARBON0DIOXIDE) ON HYDRAULIC DEVICE
• 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: 23407264
• Report Number: 1820334-2025-01339
• Device Sequence Number: 13028277
• Product Code: FAP
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K915443
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: G16705
• Device Catalogue Number: 020243
• Device Lot Number: 16674160
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/12/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2025
• 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: Unknown