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	08/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: unknown.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 (b)(6) male patient required a quick-core coaxial biopsy needle set for a lung biopsy.After insertion into the cervical lymph nodes, the coaxial needle assembly could not be unscrewed.The device was removed and replaced to successfully finish 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.Product received on: 09sep2020.Investigation ¿ evaluation.Beijing mednovo med.Tech.Co., in china, informed cook of an incident involving a quick-core coaxial biopsy needle set, after the needle punctured and reached into the cervical lymph node, the coaxial needle assembly (dtn) was difficult to unscrew.The device was removed and replaced with another to complete the procedure.No adverse effects were reported.A review of the complaint history, device history record, instructions for use (ifu), quality control, and specifications of the device, as well as a visual inspection and functional test, were conducted during the investigation.The complainant returned a coaxial needle from a quick-core coaxial biopsy needle set to cook for investigation.Inspection found the needle unscrewed with ease and the trocar slid within the cannula without difficulty.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.A correction has been implemented and the complaint device was manufactured prior to implementation of the correction.The device is shipped with instruction for use (ifu) which provides the following information to the user related to the reported failure mode: instructions for use: ¿1.If using the coaxial needle, insert the coaxial needle to the border of the lesion.7.To remove tissue specimen, pull back on the plunger until a firm click is felt.This indicates that the cutting cannula is locked into position.Push stylet forward to expose specimen within the notch, and remove tissue.¿ 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.The dhr for the complaint lot records related nonconformances.Two devices had a dtn that would not separate and were scrapped as a result.The dhr for related subassembly lots were reviewed and no nonconformances were recorded.Adequate inspection activities have been established, there is a 100% quality control inspection for the device fit/function and there is objective evidence that the dhr was fully executed.A database search revealed no other complaints from the lot at the time of the investigation.Therefore, it was concluded that there is no evidence that nonconforming product exists in house or in field.Based on the information provided, examination of the returned product, and the results of the investigation, a definitive root cause could not be established.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering 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.
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: 10468476
• Report Number: 1820334-2020-01585
• Device Sequence Number: 14051140
• Product Code: KNW
• UDI-Device Identifier: 00827002087286
• UDI-Public: (01)00827002087286(17)240423(10)9686781
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K973565
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2020

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: 04/23/2024
• Device Model Number: N/A
• Device Catalogue Number: QCS-18-15.0-10T
• Device Lot Number: 9686781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Weight: 60