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

Catalog Number	ECHO-25
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/05/2017
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.Upon evaluation of the returned device, it was noted that the needle was kinked below the sheath extender which was causing an issue advancing the needle.The kink was straightened and the needle could be advanced.The customer complaint was confirmed as the needle was kinked.Prior to distribution, all echo-25 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 records for echo-25 device of lot# c1123494 did not reveal any discrepancies that could have contributed to this complaint issue.The notes section of the instructions for use that 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, there were no adverse effects to the patient as a result of this issue.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
As reported to customer relations, "the device would not come out of the scope channel when it's sent down the scope.This device was removed and a competitors device (22 gauge) was used to complete the procedure.".
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.This follow up report is being submitted to cancel the initial report submitted in relation to this event.This event has been re-assessed as not meeting fda reporting requirements.On review of the complaint details it was determined this event did not meet the 'malfunction' reporting requirements as originally assessed.There is no malfunction reporting precedence for this event.This failure mode is also low risk and no injury has been reported as occurring to the patient.This event did not cause/contribute to a death/serious injury and is not likely to cause/contribute to a death/serious injury if it were to recur.Upon evaluation of the returned device, it was noted that the needle was kinked below the sheath extender which was causing an issue advancing the needle.The kink was straightened and the needle could be advanced.The customer complaint was confirmed as the needle was kinked.Prior to distribution, all echo-25 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 records for echo-25 device of lot# c1123494 did not reveal any discrepancies that could have contributed to this complaint issue.The notes section of the instructions for use that 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, there were no adverse effects to the patient as a result of this issue.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
This follow up report is being submitted to cancel the initial report submitted in relation to this event.This event has been re-assessed as not meeting fda reporting requirements.On review of the complaint details it was determined this event did not meet the 'malfunction' reporting requirements as originally assessed.There is no malfunction reporting precedence for this event.This failure mode is also low risk and no injury has been reported as occurring to the patient.This event did not cause/contribute to a death/serious injury and is not likely to cause/contribute to a death/serious injury if it were to recur.Initial report details: as reported to customer relations, "the device would not come out of the scope channel when it's sent down the scope.This device was removed and a competitors device (22 gauge) was used to complete the procedure.".

• Brand Name: ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 6394701
• Report Number: 3001845648-2017-00087
• Device Sequence Number: 41761
• Product Code: FCG
• UDI-Device Identifier: 00827002315198
• UDI-Public: (01)00827002315198(17)180624(10)C1123494
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K083330
• 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): 03/10/2017

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 Catalogue Number: ECHO-25
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/06/2017
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2017
• Supplement Report FDA Received Date: 04/07/2017
• Patient Sequence Number: 1