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

Model Number	G55738
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/18/2017
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: 3005580113.1 x echo-hd-25-c was returned to cirl for evaluation.On evaluation of the returned device, it was noted that the device was returned in a plastic bag.There was no syringe returned just the device itself was returned.There was no needle exposure.The kink below the sheath extender can be attributed to the conditions in which the device was returned.There is no damage to the top of the sheath.The needle is kinked/crumpled within the handle: 12cm from the hub.The customer complaint was confirmed as the needle was crumpled.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 a excessive force during the puncture /torturous anatomy.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 the notes section of the instructions for use, 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".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
The device was used for (b)(4).Though the physician attempted to puncture the pancreas head through the descending part of the duodenum, the needle did not advance.Then, olympus's ez shot 2 was used instead to complete the procedure.There have been no adverse effects to the patient reported.

• 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: 6900349
• Report Number: 3001845648-2017-00419
• Device Sequence Number: 1364997
• Product Code: FCG
• UDI-Device Identifier: 00827002557383
• UDI-Public: (01)00827002557383(17)181113(10)C1171812
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2017

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: 09/28/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2017
• Initial Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1