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

Model Number	G34874
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer name and address- postal code: (b)(6).Occupation- surgical supply chain buyer.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, a fiber was observed flaking from the inside of the sheath of a flexor parallel ureteral access sheath and dilators set.This was noted through a flexible scope used during the procedure.Additional event and patient outcome information has been requested.
Event or Problem Description
There is no new patient or event information to report.
Additional Manufacturer Narrative
Event description: as reported, a fiber was observed flaking from the inside of the sheath of a flexor parallel ureteral access sheath and dilators set.This was noted through a flexible scope used during the procedure.No adverse effects to the patient were reported.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), documentation, the instructions for use (ifu), and quality control data.One flexor parallel ureteral access sheath was returned for investigation.Inspection of the returned device noted: sheath only was returned in an opened outer package.The length of the sheath was 44.5cm there was evidence of material flaking and scraping on the inside of the sheath.Some excess material was noted along the inner edge.There is no evidence from device failure analysis that the complaint was manufactured out of specification.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 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 relevant manufacturing and quality control documents was conducted.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The instructions for use (ifu), provides no relevant information to the user related to the reported failure mode.A component failure unrelated to manufacturing or design deficiencies contributed to this incident.There are 100% inspection activities in place to identify this failure prior to distribution.The risk analysis for this failure mode was reviewed, and it was determined that no actions are 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
• MDR Report Key: 12127163
• Report Number: 1820334-2021-01699
• Device Sequence Number: 3325033
• Product Code: FED
• UDI-Device Identifier: 00827002348745
• UDI-Public: (01)00827002348745(17)240507(10)13949197
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2021

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: Health Professional
• Device Expiration Date: 05/07/2024
• Device Model Number: G34874
• Device Catalogue Number: FUS-107045-P
• Device Lot Number: 13949197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 10/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1