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

Model Number	G52012
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The following was received from the rep 12th july : ¿according to doctor (b)(6) statement on complain form, the piece was already damaged inside after opening the seal pack.He noticed the damaged piece while he was about to insert into the scope.And fourthly he didnt find any broken knob inside the pack also.¿ 1 x echo-hd-19-a was returned to cirl for evaluation.On evaluation of the used device returned, it was noted that the stylet was in place.There was no needle exposure.The thumbscrew of the brass insert of the sheath adjuster was not returned.There were markings visible on the inner handle from the needle and sheath adjuster.There are marks from the brass insert are evident, it appears the device has been used.The customer complaint was confirmed as the plastic of the sheath adjuster that holds the brass insert in place was displaced.Complaint is confirmed as the failure was verified in the laboratory.Prior to distribution, all echo-hd-19-a 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, advises the user to ¿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
Product found damaged after opening the packet.

• Brand Name: ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 6909940
• Report Number: 3001845648-2017-00421
• Device Sequence Number: 711526
• Product Code: FCG
• UDI-Device Identifier: 00827002520127
• UDI-Public: (01)00827002520127(17)190905(10)C1269549
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K092359
• 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): 09/04/2017

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: G52012
• Device Catalogue Number: ECHO-HD-19-A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/02/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2017
• Initial Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1