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

Catalog Number FUS-095045

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Occupation = non-healthcare professional.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that during the process of receiving and checking products, the logistics team identified the presence of hair-like foreign material inside the packaging of a flexor ureteral access sheath and dilator.The device was not used on a patient.

Event Description

No new patient or event information since the last report was submitted.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event summary it was reported that during the process of receiving and checking products, the logistics team identified the presence of hair-like foreign material inside the packaging of a flexor ureteral access sheath and dilator.The device was not used on a patient.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), and quality control data.Complaint device received in original unopened packaging.A visual inspection observed foreign matter inside of the pouch.The pouch was opened and a hair was confirmed to be inside the pouch.In response to this incident, cook completed a review of the dhr.The dhr for the complaint device lot records no non-conformances.A lot history search found no other complaints have been reported for this lot.Because there were no related non-conformances, adequate inspection activities had been established, there was objective evidence that the dhr was fully executed, and no other lot related complaints had been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A small hair was confirmed to be inside the sealed pouch.The cause of the issue was manufacturing: foreign material inside the pouch when sealed.Retraining of the operator was not conducted due to the small size of the hair.It was possible the hair was located behind the pouch label or product, preventing a visual inspection from finding it.Per the quality engineering risk assessment, no further action is warranted.Cook medical 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.

• Brand Name: FLEXOR URETERAL ACCESS SHEATH AND DILATORS
• Type of Device: FED ENDOSCOPIC ACCESS OVERTUBE/GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 12180176
• MDR Text Key: 261940324
• Report Number: 1820334-2021-01824
• Device Sequence Number: 1
• Product Code: FED
• UDI-Device Identifier: 10827002461670
• UDI-Public: (01)10827002461670(17)240412(10)13886162X
• Combination Product (y/n): N
• PMA/PMN Number: K172217
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: FUS-095045
• Device Lot Number: 13886162X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Date Manufacturer Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1