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

Model Number	G56436
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: customer postal code= (b)(6).E1: customer fax:(b)(6).E3: customer occupation = unknown.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.
Event or Problem Description
It was reported, the flexor parallel ureteral access sheath and dilators' package was not sealed properly and the device "fell out".The issue was discovered while the device was in the warehouse.
Additional Manufacturer Narrative
Event description: it was reported, the flexor parallel ureteral access sheath and dilators' package was not sealed properly and the device "fell out".The issue was discovered while the device was in the warehouse.Investigation ¿ evaluation: 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), manufacturing instructions, and quality control procedures.One flexor parallel ureteral access sheath and dilators was returned in an open, labeled package.Upon inspection no damage to the device was noticed.Package does not have a cook applied seal.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 no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there were no related non-conformances, adequate inspection activities have been established, there was objective evidence that the dhr was fully executed, and no other complaints from the lot had been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in the field.The returned device was found to have a pouch that was not sealed.The cause was a manufacturing issue in that the packaged was not sealed and a quality issue in that the seal was not inspected.The appropriate manufacturing and quality persons were notified of the issue.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: FLEXOR PARALLEL 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: 20836075
• Report Number: 1820334-2024-01587
• Device Sequence Number: 11776916
• Product Code: FED
• UDI-Device Identifier: 00827002564367
• UDI-Public: (01)00827002564367(17)270911(10)16245433
• Combination Product (Y/N): N
• PMA/510(K) Number: K172217
• 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): 05/29/2025

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: G56436
• Device Catalogue Number: FUS-120045-P
• Device Lot Number: 16245433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2024
• 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: Unknown