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	06/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 required for an ultrasound guided neck node biopsy procedure in a male patient.Prior to patient contact, the operator reported the stylet of the coaxial needle "got stuck." 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: 21jul2020.Investigation ¿ evaluation.It was reported to cook that the stylet within a quick-core coaxial biopsy needle set became stuck within the coaxial needle.This incident was reported by malabar institute of medical sciences ltd (mims), in india.No adverse effects were reported.A review of the complaint history, device history record, drawing, 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.The complainant returned one dtn assembly to cook for investigation.Physical examination of the returned device showed: one coaxial needle returned prior to use.The dtn needle could not be separated by hand, so channel locks were used to separate the needle and cannula.The needle and cannula were screwed back together and were able to be unscrewed by hand.All dimensions deemed relevant to the reported failure were analyzed (stylet od, cannula id) and confirmed that the device was within specification.Additionally, a document-based investigation evaluation was performed.Although inspection steps are in place related to this failure mode, a project was opened to further investigate/address this issue.The instructions for use (ifu) were reviewed for information related to reported failure mode.The ifu provides the following information to the user related to the reported failure mode: 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 for the reported lot and subassembly lot.The results revealed no relevant non-conformances.A complaints database search was completed for the reported lot.There were no additional complaints reported from the field.At this time, cook concluded that no nonconforming product from this lot exists in house or in the field.It is possible that the device was screwed too tightly during quality control, but this potential cause of failure cannot be confirmed.Another unknown factor may be contributing to the dtn becoming unable to be unscrewed.Based on the information provided, visual inspection of returned product, and results of the investigation, a main contributing cause of failure 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.
Additional Manufacturer Narrative
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.
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: 10247503
• Report Number: 1820334-2020-01273
• Device Sequence Number: 14238558
• Product Code: KNW
• UDI-Device Identifier: 00827002087286
• UDI-Public: (01)00827002087286(17)250203(10)NS10304904
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K973565
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/17/2020

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: 02/03/2025
• Device Model Number: N/A
• Device Catalogue Number: QCS-18-15.0-10T
• Device Lot Number: NS10304904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 07/13/2020; 08/12/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 07/16/2020; 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1