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

Catalog Number	QCS-18-9.0-20T
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: k973565.(b)(4).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 quick-core coaxial biopsy needle set was being tested during pre-op and the introducer was faulty.The cap on the introducer was unable to be unscrewed; therefore, the needle could not be put through.As reported, this occurred prior to patient contact.
Additional Manufacturer Narrative
Investigation evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions and quality control was conducted during the investigation.No complaint device has been returned for investigation.No photos have been provided.However, a document-based investigation was conducted.A device history record of the lot was reviewed and found no non-conformances for either the device or component coaxial support needle.A review of complaints from the same lot was conducted and found no reported complaints associated with this lot number.The customer has been unresponsive and has not provided updated information on if the device will be returned.If the complaint device becomes available for investigation in the lab, the device will be evaluated and the file will be updated at that time.Based on the information provided, no product returned, and the results of our investigation, two possible root causes have been identified as manufacturing related (operator related/process related).We have notified the appropriate personnel and will continue to monitor for similar complaints.Per quality engineering risk assessment, there is no further actions required at this time.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 new event description information to report at this time.

• 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: 7504479
• Report Number: 1820334-2018-01405
• Device Sequence Number: 210118
• Product Code: KNW
• UDI-Device Identifier: 00827002270176
• UDI-Public: (01)00827002270176(17)230131(10)8552279
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2018

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 Catalogue Number: QCS-18-9.0-20T
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/25/2018
• Supplement Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 06/29/2018
• Patient Sequence Number: 1