MAUDE Adverse Event Report: COOK INC QUICK-CORE COAXIAL BIOPSY NEEDLE SET; KNW INSTRUMENT, BIOPSY

Model Number	N/A
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date received by manufacturer: the physical evaluation of the returned device confirmed a reportable failure mode.Further investigation details are forthcoming.Pma/510(k) #: k973565.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 originally reported the stylet and needle from a quick-core coaxial biopsy needle set "is not opened".The device was selected for use in an omental biopsy.The device was tested prior to patient contact and "could not be removed".Due to a lack of inventory of the device, the procedure was rescheduled for the next morning.The device did not make patient contact.On 29-jan-2019 the device was returned to aid in the investigation.The physical evaluation of the returned device confirmed a reportable failure mode.Further investigation details are forthcoming.As reported, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection, functional test, and supplier investigation, were conducted during the investigation.The device inspection found the trocar stylet and cannula were able to be disconnected with greater hand force than normal.No damage was noted to either device and the threads appeared normal.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.The supplier provided component reviewed relevant lot records and determined that no conclusion could be made at this time to account for the difficulty experienced by the user facility.Based on the information provided, the examination of the returned product, and the results of the investigation, cook has concluded that a quality control deficiency contributed to this incident.Appropriate measures are being conducted to address this failure mode.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.
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: 8306983
• Report Number: 1820334-2019-00117
• Device Sequence Number: 19098599
• Product Code: KNW
• UDI-Device Identifier: 00827002270169
• UDI-Public: (01)00827002270169(17)230228(10)8632885
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2019

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: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: QCS-18-9.0-10T
• Device Lot Number: 8632885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1