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

Model Number	G14919
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common name & product code- kod- catheter, urological pma/510(k) #- k182231.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 via mw5101086, a ureteral brush biopsy set separated inside another manufacturer's scope.The device was passed through the scope.When removed from the scope, it was noted that the brush was no longer attached to the device.A second brush was opened to complete the procedure.Intraoperative x-ray was used to verify that the brush did not remain in the patient.No adverse effect to the patient was reported as a result of this occurrence.Additional patient and event information have been requested.
Additional Manufacturer Narrative
Event description: as reported via mw5101086, a ureteral brush biopsy set separated inside another manufacturer's scope.The device was passed through the scope.When removed from the scope, it was noted that the brush was no longer attached to the device.A second brush was opened to complete the procedure.Intraoperative x-ray was used to verify that the brush did not remain in the patient.Attempts to acquire additional information from the user facility were executed, however no additional information was provided to cook in response to this incident.No adverse effect to the patient was reported as a result of this occurrence.Investigation ¿ evaluation: a document based investigation was performed including a review of complaint history, device history record (dhr), and quality control data.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest this device was manufactured out of specification.No photos were provided.A search of our north american distribution center (nadc) database found all devices from the reported lot had been shipped.There was no similar product from the same lot available for investigation.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.The product specification for the device was reviewed and all devices are 100% pull tested to ensure the integrity of the bush assembly.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The complaint device was not returned and the customer did not respond to any requests for additional information related to the reported issue.The nature and cause of the reported issue could not be determined.The risk assessment 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.
Event or Problem Description
There is no new patient or event information to report.

• Brand Name: URETERAL BRUSH BIOPSY SET
• Common Device Name: FDX ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11922229
• Report Number: 1820334-2021-01443
• Device Sequence Number: 3403834
• Product Code: KOD
• UDI-Device Identifier: 00827002149199
• UDI-Public: (01)00827002149199(17)231201(10)13597835
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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: 12/01/2023
• Device Model Number: G14919
• Device Catalogue Number: 040310
• Device Lot Number: 13597835
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STORZ SCOPE