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	10/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: k973565.Investigation ¿ evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control and specifications of the device, as well as a dimensional verification, visual inspection, and functional test, were conducted during the investigation.Upon visual inspection, no surface damage was found on the device.The needle was not able to be unscrewed by hand, but was able to be removed with channel locks.The threads did not appear damaged.The device dimensions were measured and found to be within specifications.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 indicated no non-conformance for this lot.A review of the relevant subassemblies and raw materials found no non-conformances.It should be noted there were no other reported complaints for this lot number.A supplier investigation was requested for the relevant subassembly lots.No non-conformances on the affected lots were found and no root cause could be established due to manufacturing processes or handling by the supplier.The device is shipped with an instructions for use (ifu) which states: ".Upon removal from package, inspect the product to ensure no damage has occurred.".Based on the information provided, the examination of the returned product, and the results of our investigation, the failure is most likely manufacturing related.Appropriate measures have been taken to address this failure mode.The appropriate personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
It was reported the inner stylet was jammed in the coaxial needle from a quick-core coaxial biopsy needle set before a lung biopsy procedure.The cannula was found not to separate from the needle prior to the procedure and the device did not make patient contact.The procedure was completed with another quick-core coaxial biopsy needle set.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

• 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: 8258111
• Report Number: 1820334-2019-00116
• Device Sequence Number: 16623062
• Product Code: KNW
• UDI-Device Identifier: 00827002270169
• UDI-Public: (01)00827002270169(17)221220(10)8461035
• 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
• Report Date (Section B): 01/17/2019

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: 12/20/2022
• Device Model Number: N/A
• Device Catalogue Number: QCS-18-9.0-10T
• Device Lot Number: 8461035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1