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

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/07/2019
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 lung biopsy.As reported, prior to patient contact it was found "the stylet of the guiding needle was stuck/jammed and could not be removed." another similar device was used to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
D10 ¿ concomitant medical product received on: 04sep2019.Investigation ¿ evaluation.It was reported that the stylet of the guiding needle from a quick-core coaxial biopsy needle set was stuck/jammed.Further communication with the user facility clarified that the device did not make patient contact, and that a replacement device was opened and used to compete the lung biopsy.Cook became aware of this upon being notified by a doctor from (b)(6) medical.The patient reportedly experienced no adverse effects as a result of this incident.A review of the complaint history, device history record, drawing, instructions for use (ifu), quality control, and specifications of the device, as well as a visual inspection, functional test, and dimensional verification, were conducted during the investigation.The complainant returned a coaxial needle subassembly to cook for investigation.No damage was noted on the surface.The dtn was able to be easily unscrewed by hand.Dimensions such as stylet outer diameter and cannula inner diameter were measured within specification.Additionally, a document-based investigation evaluation was performed.The risks associated with these devices are acceptable when weighed against the benefits.Although inspection steps are in place related to this failure mode, a project was opened to further investigate/address this issue.Product labeling was also reviewed.Instructions for use are packaged with this device.Relevant sections include: intended use: quick-core biopsy needles are intended for soft tissue biopsy.The product is intended for use by physicians trained and experienced in diagnostic and interventional techniques.Standard techniques for soft tissue biopsy should be employed.How supplied: upon removal from package, inspect the product to ensure no damage has occurred.The device history record (dhr) was reviewed.The complaint lot showed no related nonconformance.The coaxial needle subassembly lot showed no nonconformance.A database search revealed no other complaints from the lot at the time of investigation.Since there are no related nonconformance or other complaints from this lot, there is no evidence that nonconforming product exists in house or in the field.It is possible that the device was screwed too tightly during quality control, but this cannot be definitively confirmed since the returned device was able to be unscrewed by hand.Another unknown factor may be contributing to the dtn becoming unable to be unscrewed.Based on the information provided, inspection of the returned product, and the results of the investigation, a definitive cause could not be established.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.

• 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: 8900640
• Report Number: 1820334-2019-02026
• Device Sequence Number: 290651
• Product Code: KNW
• UDI-Device Identifier: 00827002087286
• UDI-Public: (01)00827002087286(17)240212(10)9516679
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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: 02/12/2024
• Device Model Number: N/A
• Device Catalogue Number: QCS-18-15.0-10T
• Device Lot Number: 9516679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1