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 Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter's occupation: purchasing.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, upon delivery of a flexor parallel ureteral access sheath and dilators, it was discovered that the package was open due to a missing seal.The issue was discovered in the purchasing department and there was no patient involvement.
Additional Manufacturer Narrative
Description of event: as reported, upon delivery of a flexor parallel ureteral access sheath and dilators, it was discovered that the package was open due to a missing seal.The issue was discovered in the purchasing department and there was no patient involvement.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, the instructions for use, manufacturing instructions, and quality control data.The complaint device was returned in package with the chevron end open.The straight seal was completely missing.The distal tip of dilator was kinked for approximately 5 mm.A review of the device history record found no non-conformances related to the reported failure mode.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 there is no evidence that nonconforming product exists in house or in the field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied "do not use the product if there is doubt as to whether the product if there is doubt as to whether the product is sterile." a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded a manufacturing event likely contributed to this incident.The employee responsible for the production of an out of specification device has been retrained.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database 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.
Event or Problem Description
No new patient or event information to report.

• 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
• MDR Report Key: 11196062
• Report Number: 1820334-2021-00120
• Device Sequence Number: 642360
• Product Code: FED
• UDI-Device Identifier: 00827002564367
• UDI-Public: (01)00827002564367(17)231029(10)13521525
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K172217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

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: No Information
• Device Expiration Date: 10/29/2023
• Device Model Number: G56436
• Device Catalogue Number: FUS-120045-P
• Device Lot Number: 13521525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1