MAUDE Adverse Event Report: COOK INC URETERAL BRUSH BIOPSY SET; FDX ENDOSCOPIC CYTOLOGY BRUSH

Model Number G14090

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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, a red, rust like material was discovered inside the unopened package of a ureteral brush biopsy set.No adverse events have been reported as a result of the alleged malfunction.

Manufacturer Narrative

Investigation - evaluation: (b)(6) hospital informed cook on 12/24/2019 of an incident involving a ureteral brush biopsy set rpn 040000 from lot # 9985949.The package of the device reportedly was found to have foreign matter like red rust inside.The issue was discovered before the device was used in a procedure.A visual inspection of the unused returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, documentation, manufacturing instructions, specifications, and quality control data.One unopened device was returned for investigation.Visual exam notes red flux residue loose in the unopened package.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 are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The package of the unopened returned device was found to have foreign matter inside.The foreign matter was red flux residue that was loose in the package.Flux is used during the soldering process during manufacturing.The manufacturing instructions for the biopsy brush device state that all solder joints must be dipped into an ultrasound and cleaning solution to remove flux.The brush assembly must also be cleaned and left overnight to dry.For the complaint device, it is likely the device was not adequately cleaned during manufacturing.The flux residue was likely not visible on the finished device with the brush assembly inside the sheath.During transport, the flux was likely shaken out of the catheter, becoming visible in the pouch.The cause of the complaint was manufacturing issue.The operator involved has been retrained.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.

Event Description

No additional patient and event information since the last report was submitted.

• Brand Name: URETERAL BRUSH BIOPSY SET
• Type of Device: FDX ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9544565
• MDR Text Key: 178332790
• Report Number: 1820334-2020-00045
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 00827002140905
• UDI-Public: (01)00827002140905(17)220903(10)9985949
• Combination Product (y/n): N
• PMA/PMN Number: K770913
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2022
• Device Model Number: G14090
• Device Catalogue Number: 040000
• Device Lot Number: 9985949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1