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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2021
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 that the white cap of a quick-core coaxial biopsy needle was difficult to rotate.The device was required by an unknown patient for an unknown procedure.The user confirmed that the inner needle of the coaxial needle could be removed without difficulty; however the white cap was "too hard to be rotated".The device did not have patient contact.A new, like device was used to successfully complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation.Ena hospital in japan contacted cook stating that when they went to use the dtn needle from a qcs-18-9.0-10t from lot# 13706670, the inner needle could not be rotated and removed.The customer used a different qcs-18-9.0-10t set to complete the procedure.There were no adverse effects for the patient.A review of the complaint history, device history record, drawing, instructions for use (ifu), and quality control of the device, as well as a visual inspection, functional test, and dimensional verification of the returned device, were conducted during the investigation.The device was returned for evaluation.The customer stated that they couldn¿t get the hub of the inner needle to unscrew, however, during tabletop testing the device was able to be unscrewed without difficulty.All relevant measurements were within specification.Additionally, a document based investigation evaluation was performed.A review of the device master record concluded there are process checks during the manufacturing process to check for this failure and prevent non-conforming product from leaving house.The device is shipped with instruction for use (ifu) which provides the following information to the user related to the reported failure mode: "how supplied: upon removal from package, inspect the product to ensure no damage has occurred." a review of the device history record (dhr) was also conducted as a part of the investigation to check for failure related nonconformances and additional complaints.Lot# 13706670 did not have any non-conformances.There are no additional complaints for this lot.There is no evidence of non-conforming material in house or in the field.A project was previously opened to investigate this failure mode and updates were made to quality control inspections.This device was manufactured before this correction.Therefore, cook concluded that the cause of this event is quality control deficiency.The appropriate internal personnel have been notified.Per the 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: 12468417
• Report Number: 1820334-2021-02153
• Device Sequence Number: 4891783
• Product Code: KNW
• UDI-Device Identifier: 00827002270169
• UDI-Public: (01)00827002270169(17)260121(10)13706670
• 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
• Report Date (Section B): 01/19/2022

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: 01/21/2026
• Device Model Number: N/A
• Device Catalogue Number: QCS-18-9.0-10T
• Device Lot Number: 13706670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2021
• 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