MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY

Model Number	G55738
Medical Device Problem Codes	Bent (1059); Kinked (1339)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # k142688.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Investigation is pending.A follow up mdr will be submitted with the investigation conclusions.
Event or Problem Description
Physician did eus-fnb in pancreas head puncture but the needle didn't puncture at all.He used another echo-hd-25-c and procedure did successfully.
Additional Manufacturer Narrative
Pma/510(k) # k142688.(b)(4).Exemption number: e2016031.Importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).Lab evaluation: 1 x echo-hd-25-c from lot number c1340872 was returned to cirl for evaluation.On evaluation of the returned device, it was noted that the device was returned in its original packaging.The stylet was completely removed from the device.There was no needle exposure.The syringe was returned with the device.The needle advances and retracts without any issues.The stylet advances as far as the kink below the sheath extender.There were no issues noted with the needle.The brass insert was protruding-no cracking.There was a kink on the sheath extender this was potential caused by the customer when removing the device from the packaging or by inserting onto the scope this complaint relates to the needle kinking below the sheath extender.The customer complaint is confirmed as the failure was verified in the lab, as per the kink identified below the sheath extender.A definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could not be replicated in the laboratory setting, possible causes may be due to the device becoming kinked on removal of the device from the packaging or possibly may have become damaged when inserting the device into the scope.Prior to distribution, all echo-hd-25-c devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing record for echo-hd-25-c device of lot number c1340872 , ch1332088 did have an nc code gen-066 which was damaged by machine this needle was scrapped and the device was re-wroked with a new needle.This nc code could not have contributed to this occurrence.The notes section of the instructions for use, ifu0077-4, which accompanies this device instructs the user to inspect the device prior to use for any damage: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".On review of the information provided, there is no viable evidence to suggest that the user did not follow the instructions for use.From the information provided, no adverse effects to the patient have been reported as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
This follow up mdr is being submitted to include the investigation conclusions.Correction to manufacturer informed date also.Physician did eus-fnb in pancreas head puncture but the needle didn't puncture at all.He used another echo-hd-25-c and procedure did successfully.

• Brand Name: ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7014008
• Report Number: 3001845648-2017-00515
• Device Sequence Number: 16172703
• Product Code: FCG
• UDI-Device Identifier: 00827002557383
• UDI-Public: (01)00827002557383(17)200328(10)C1340872
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2017

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: G55738
• Device Catalogue Number: ECHO-HD-25-C
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/03/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 11/09/2017
• Supplement Report FDA Received Date: 11/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1