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	07/18/2022
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.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
It was reported the needle assembly of a quick-core coaxial biopsy needle set was unable to be unscrewed prior to a lung puncture procedure that occurred on (b)(6) 2022.The user had to use tools to unscrew the trocar.The procedure was completed successfully with a new, like device.The patient did not experience any adverse effects 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
Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation: shanghai huirong med.Science (china) contacted cook on 20jul2022 concerning the needle in a quick-core coaxial biopsy needle set (rpn: qcs-18-15.0-20t; lot# 14425881).It was reported that on 18jul2022 a 49-year-old female patient, weighing 56 kg underwent a lung puncture.During the procedure, the user had difficulty separating the inner cannula of the dtn needle provided in this set.The needle was replaced with a new device and the procedure was completed.Tools had to be used to separate the inner cannula of the dtn.No adverse effects were reported due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), quality control procedures, and specifications of the device, as well as a visual inspection and functional test of the returned device, were conducted during the investigation.Cook received one prior to use device and fourteen sealed devices.Resistance was noted with four of the sealed devices, but the inner cannula was able to be separated.With the prior to use device, tools were needed to separate the inner cannula of the dtn.The reported failure was confirmed on the prior to use device and the four sealed devices.Measurements of the inner and outer diameters of the devices were taken and found to be out of specification.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the device history record (dhr).The dhrs for lot 14425881 and dtn sub-assembly lot, sa13770232, record no relevant non-conformances or other complaints.The information provided upon review of the returned device suggests that the device was manufactured out of specification.There is no evidence of non-conforming material in house or in the field.Cook reviewed product labeling.This product is supplied with an instructions for use (ifu) pamphlet, t_qc_rev6.In the instructions for use section, it states: 1.) if using the coaxial needle, insert the coaxial needle to the border of the lesion.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 the returned device, and the results of the investigation, cook determined the cause of this event is related to a quality control deficiency.A defect awareness was sent to the appropriate department and has been acknowledged and signed.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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
• 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: 15113328
• Report Number: 1820334-2022-01284
• Device Sequence Number: 12128557
• Product Code: KNW
• UDI-Device Identifier: 00827002087903
• UDI-Public: (01)00827002087903(17)261216(10)14425881
• 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,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2022

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 Model Number: N/A
• Device Catalogue Number: QCS-18-15.0-20T
• Device Lot Number: 14425881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2021
• 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 Age: 49 YR
• Patient Sex: Female
• Patient Weight: 56 KG