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

Model Number	N/A
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k): k973565.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 a quick-core coaxial biopsy needle set was selected for use in a breast biopsy in a female patient.The report states the user had trouble with the coaxial needle becoming ¿jammed¿ prior to use.Additional information regarding the patient outcome has been requested but is currently unavailable.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Product received on: (b)(6) 2019.Investigation ¿ evaluation: a review of the complaint history, device history record, drawing, documentation, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection, functional test, and dimensional verification, were conducted during the investigation.Cook received three opened but unused devices.Physical examination showed some resistance when attempting to unscrew the coaxial needle subassembly.Retightening the coaxial subassembly recreates the failure mode.Relevant dimensions such as the stylet outer diameter and cannula inner diameter were measured within specification.Based on this information, the returned devices cannot be confirmed to be manufactured out of specification.Additionally, a document based investigation evaluation was performed.Action has been taken to address a potential quality gap relating to this failure mode.A review of the device history record showed no nonconforming events which could contribute to this failure mode.A database search revealed two other complaints under this lot.Actions were previously taken to address this failure mode and found the failure mode was related to a manufacturing step, not the device lots.The risk assessment determined that no risk reduction is necessary.This decision is still valid since the failure mode is related to a manufacturing step concerning the product line, and the risk assessment conclusion has not changed.Based on the information provided, inspection of returned product and the results of the investigation, cook has concluded that the main cause of failure is likely to be manufacturing-related, traced to a quality control deficiency.Action has been taken to address a potential quality gap relating to this failure mode.Appropriate measures are being conducted to address this failure mode.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
• MDR Report Key: 8590435
• Report Number: 1820334-2019-01108
• Device Sequence Number: 14027048
• Product Code: KNW
• UDI-Device Identifier: 00827002270169
• UDI-Public: (01)00827002270169(17)231120(10)9326859
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2019

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: 11/20/2023
• Device Model Number: N/A
• Device Catalogue Number: QCS-18-9.0-10T
• Device Lot Number: 9326859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1