MAUDE Adverse Event Report: COOK INC QUICK-CORE COAXIAL BIOPSY NEEDLE SET

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common name: instrument, biopsy; biopsy needle kit.Procode: knw.510k#: k973565.Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be established.Though the root cause in this case was not established, a past complaint for a similar device and failure mode concluded that the main cause of failure is manufacturing-related, although this could not be confirmed as no complaint device was returned to aid in our investigation.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.
Event or Problem Description
It was originally reported that the international customer was unable to start using the needles without using what was believed to be an inordinate amount of force.After the application of this force, the complaint device was deployed and the procedures were successfully completed.It was discovered during the investigation portion of the evaluation of this incident that the failure mode as reported by the customer likely describes a difficulty in separating the needle and the cannula.

• Brand Name: QUICK-CORE COAXIAL BIOPSY NEEDLE SET
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8301967
• Report Number: 1820334-2019-00351
• Device Sequence Number: 16181556
• Product Code: FCG
• UDI-Device Identifier: 00827002087286
• UDI-Public: (01)00827002087286(17)230502(10)8859138
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2019

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: 05/02/2023
• Device Model Number: N/A
• Device Catalogue Number: QCS-18-15.0-10T
• Device Lot Number: 8859138
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 02/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1