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

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
(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
Customer reported opening an unused quick-core coaxial biopsy needle set to evaluate for ease of use.The customer reported that the stylet is "extremely difficult to get it out." there was no patient contact, accordingly no adverse patient consequence.The device is anticipated to be returned for evaluation.
Additional Manufacturer Narrative
Correction(s): from adverse event/product problem to product problem.Investigation - evaluation: a review of documentation, manufacturing instructions, specification and quality control data was conducted during the investigation.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Ten quick-core biopsy needle sets were returned.There was one set where the coaxial needle assembly is opened.The trocar needle stylet was locked into the 16 gauge outer cannula.The investigator twisted the hub and, with some difficulty, the hub was unlocked and stylet removed from the outer cannula.The operator was met with resistance and some excessive force needed to be applied to unlock the hub initially.Once the hub was unlocked the first time, the stylet slid easily in and out of the outer cannula and unlocking the hub again did not prove to be difficult.The other nine sets were opened and the coaxial needle assembly removed.The trocar needle stylet was unlocked and removed from the outer cannula easily and without much resistance/force in all nine cases.Current risk controls include the cannula and stylet design with proper tolerances and design to be used together, verification of the fit between the stylet and cannula, and final inspection of the assembly prior to shipping.It is feasible to suggest that during the assembly/manufacturing process, too much force was applied to the hub of the trocar needle stylet when attaching with the sdn needle cannula.This would cause an over-tightening of the needle stylet hub to the cannulas luer locking hub and make removal of the needle stylet difficult during the procedure.Based on a review of complaint history, this failure mode has occurred numerous times in the past.Based on the provided information a root cause of the event is related to the operational context.We have notified the appropriate personnel and will continue to monitor for similar complaints.Per the risk assessment no further action is required.

• Brand Name: QUICK-CORE COAXIAL BIOPSY NEEDLE SET
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6683456
• Report Number: 1820334-2017-01456
• Device Sequence Number: 137445
• Product Code: FCG
• UDI-Device Identifier: 00827002270176
• UDI-Public: (01)00827002270176(17)220301(10)7714892
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2017

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-18-9.0-20T
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/07/2017
• Supplement Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 07/01/2017
• Supplement Report FDA Received Date: 09/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1