MAUDE Adverse Event Report: COOK INC QUICK-CORE COAXIAL BIOPSY NEEDLE SET; KNW INSTRUMENT, BIOPSY

Model Number	G08728
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer (person): postal code: (b)(6).Phone: (b)(6).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
It was reported the inner stylet of a quick-core coaxial biopsy needle set was difficult to remove from the coaxial needle.This occurred prior to patient contact.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Event or Problem Description
The patient was in the ct scanner as the physician checked that the coaxial parts all came apart before placing the introducer into the patient.There was no patient contact.The procedure was completed successfully with another biopsy needle.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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.
Additional Manufacturer Narrative
Investigation ¿ evaluation birmingham heartlands (united kingdom) contacted cook stating that when they went to use a qcs-18-15.0-10t set from lot# 10304907, the coaxial inner needle would not separate easily.The patient did not require any additional procedures and the patient had no adverse effects due to this event.A review of the complaint history, device history record, drawing, instructions for use (ifu) and quality control, as well as a visual inspection and function test of the returned device was conducted during the investigation.The product was returned to cook for evaluation.Device evaluation found the trocar stylet was able to be unscrewed with channel locks.The failure was confirmed during the evaluation.There are process checks during the manufacturing process to check these devices to ensure that no non-conforming devices leave house.The device history record for lot# 10304907 was reviewed.Lot# 10304907 had no non-conformances.There are no additional complaints for this lot.Based on the device master record, the device history record, and the device failure analysis, there in no indication the device was manufactured out of specification.There is no evidence of non-conforming material in house or in the field.The supplied instructions for use (ifu) for this device was reviewed.In the "how supplied" section it states: upon removal from package, inspect the product to ensure no damage has occurred.Based on the information provided, inspection of returned product and the results of the investigation, it was concluded that the cause of the event is quality control deficiency.A project was previously opened to investigate this failure and updated the quality control inspections.The device was manufactured before this correction.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: QUICK-CORE COAXIAL BIOPSY NEEDLE SET
• Common Device Name: KNW INSTRUMENT, BIOPSY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 12460159
• Report Number: 1820334-2021-02143
• Device Sequence Number: 1207388
• Product Code: KNW
• UDI-Device Identifier: 00827002087286
• UDI-Public: (01)00827002087286(17)250203(10)10304907
• Combination Product (Y/N): N
• PMA/510(K) Number: K973565
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/09/2021

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: 02/03/2025
• Device Model Number: G08728
• Device Catalogue Number: QCS-18-15.0-10T
• Device Lot Number: 10304907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 09/23/2021; 12/03/2021
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 09/28/2021; 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown