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

Model Number	N/A
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 510k # - k973565.(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The international customer reported that, prior to patient contact, the needle in the quick-core coaxial biopsy needle set would not pull out of the cannula.The operator employed another new device to finish the procedure successfully, with not further complications reported.The customer confirmed that no adverse effects occurred as a result of the product issue.The product was received for evaluation; however, as of the date of this report, the investigation is still pending.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the device history record, documentation, drawing, instructions for use, manufacturing instructions, quality control, specifications, as well as a visual inspection of the actual device and dimensional verification was completed during this investigation.The manufacturing documents in place at the time of manufacture were reviewed and it was found that the device aspect in question was visually inspected by quality control and no notable gaps in production or processing controls were noted.The risk specification for this product includes the failure mode of incompatibility between the stylet and the cannula and identifies that multiple risk controls are in place to mitigate the risk of this type of failure.The device history records were reviewed and no non-conformances were found.A complaint history search revealed this to be the only complaint reported for associated lots at the time of investigation.An opened, unused product was returned.Measurements of the needle and cannula were performed and it was found that the device was manufactured to specification.The reported failure could not be duplicated.With the provided information, the root cause of the failure is unknown.A quality engineering risk assessment determined that no additional actions are required at this time.We will continue to monitor for similar complaints.

• 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: 6914357
• Report Number: 1820334-2017-03481
• Device Sequence Number: 19193360
• Product Code: KNW
• UDI-Device Identifier: 00827002087286
• UDI-Public: (01)00827002087286(17)220227(10)7708387
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2017

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 Model Number: N/A
• Device Catalogue Number: QCS-18-15.0-10T
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 10/04/2017
• Supplement Report FDA Received Date: 11/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1