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	10/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1 - customer (person): phone: (b)(6).E3 - occupation: agent.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 stylet of a quick-core coaxial biopsy needle set was difficult to separate from the coaxial needle during a lung biopsy for an unknown patient.Before the procedure, the outer packaging of the product was checked, and no damage was found.After opening the package and removing the device, it was found that the coaxial needle could not be unscrewed as normal.The stylet was noted to be screwed too tightly and could not be separated from the outer part of the needle.After experiencing this issue with four different devices of the same lot within the same procedure, the fifth device functioned as intended and the procedure was able to be completed.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
Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation: it was reported the stylet of a quick-core coaxial biopsy needle set was difficult to separate from the coaxial needle during a lung biopsy for an unknown patient.Before the procedure, the outer packaging of the product was checked, and no damage was found.After opening the package and removing the device, it was found that the coaxial needle could not be unscrewed as normal.The stylet was noted to be screwed too tightly and could not be separated from the outer part of the needle.After experiencing this issue with four different devices of the same lot within the same procedure, the fifth device functioned as intended and the procedure was able to be completed.No adverse effects have been reported.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), quality control procedures, and specifications of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 reviewed the dhr for the reported lot.No nonconformances or additional complaints were found.The dtn subassembly lot also showed no nonconformances.Based on the dmr and dhr there is no indication the complaint device was manufactured out of specification.Cook did not identify any nonconforming material in house or in the field.Cook also reviewed product labeling.The product ifu, [t_qc_rev5] ¿quick-core biopsy needles and sets,¿ provides the following information to the user related to the reported failure mode: how supplied ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, no device return, and the results of the investigation, cook concluded a cause could not be established for this event.It is possible that the needles were over tightened during qc, however this cannot be confirmed without additional information.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: d9, h3 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 patient and/or event details 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: 17916512
• Report Number: 1820334-2023-01374
• Device Sequence Number: 2957090
• Product Code: KNW
• UDI-Device Identifier: 00827002087903
• UDI-Public: (01)00827002087903(17)250416(10)13139537
• 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,Followup
• Report Date (Section B): 03/08/2024

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: 04/16/2025
• Device Model Number: N/A
• Device Catalogue Number: QCS-18-15.0-20T
• Device Lot Number: 13139537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 02/03/2024; 02/23/2024
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 02/20/2024; 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2020
• 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