MAUDE Adverse Event Report: COOK INC FLEXOR URETERAL ACCESS SHEATH AND DILATORS; FED, ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY

Model Number	G34880
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, the flexor ureteral access sheath and dilators, was used for a transurethral lithotripsy (tul) procedure and after the urinary stones were crushed with basket forceps; during the collection of the fragments a thread-like foreign object was found in the urinary tract.It is believed that the foreign object may be a part of the lumen of the product (abrasion/scraping).The device was retrieved, and the use of the device was discontinued.Another same type device was used to complete the procedure.An image of what appears to show foreign object was provided.No section of the device remained inside the patient's body.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 or unavailable.E1 ¿(b)(6).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, unavailable, or unchanged.Investigation ¿ evaluation.It was reported, the flexor ureteral access sheath and dilators, was used for a transurethral lithotripsy (tul) procedure and after the urinary stones were crushed with basket forceps; during the collection of the fragments a thread-like foreign object was found in the urinary tract.It is believed that the foreign object may be a part of the lumen of the product (abrasion/scraping).The device was retrieved, and the use of the device was discontinued.Another same type device was used to complete the procedure.An image of what appears to show foreign object was provided.No section of the device remained inside the patient's body.The complainant has not reported any adverse effects on the patient due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturer¿s instructions (mi), quality control (qc) procedures, as well as a visual inspection of the returned device were conducted during the investigation.A device was returned for investigation without package or label.Upon inspection there was a foreign substance on both the dilator and sheath hubs.When taking the device apart it was very difficult and there was evidence of a clear fiber like material in the sheath hub and on the body of the dilator.This same material was returned in a separate container with the device.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 no non-conformances reported for lot.A complaint history database search showed no other related complaints associated with the failure mode for the complaint device lot.Because there are no related non-conformances, 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, it was concluded that the device was manufactured to specification and there is no evidence that nonconforming product exists in house or in field.Cook also reviewed product labeling.The ifu supplied with the device does not provide any information related to the reported issue.A clear fiber like material was observed coming out of the distal end of the sheath.The material was likely the inner lining of the sheath.It is possible that the other devices inserted through the scope peeled the liner.No information was known about other devices used in the procedure.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 conclusively 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: FLEXOR URETERAL ACCESS SHEATH AND DILATORS
• Common Device Name: FED, ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY
• 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: 21877664
• Report Number: 1820334-2025-00420
• Device Sequence Number: 20763116
• Product Code: FED
• UDI-Device Identifier: 00827002348806
• UDI-Public: (01)00827002348806(17)271108(10)16333203X
• Combination Product (Y/N): N
• PMA/510(K) Number: K172217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

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: G34880
• Device Catalogue Number: FUS-107045
• Device Lot Number: 16333203X
• 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: 04/02/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC/FLEXIBLE URETEROSCOPE LITHO VUE.
• Patient Sex: Unknown