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

Model Number	G55736
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2017
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 it was originally indicated that the device involved in this complaint was being returned to cook ireland for evaluation; the device has not yet been received, however, if it is returned, the device will be evaluated and the investigation will be updated.As the device was not returned for evaluation; the cause of this complaint could not be conclusively determined.With the information provided a document based investigation was carried out.The customer complaint is considered to be confirmed based on customer testimony.Prior to distribution, all echo-hd-22-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 records for echo-hd-22-c device of lot# c1284032 did not reveal any discrepancies that could have contributed to this complaint issue.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
This initial mdr is being submitted as the overall risk was assessed as moderate.The risk is not considered to be 'remote'.As reported to customer relations: "the needle lock wouldn't work, which caused the entire needle to come out instead of desired length." district manager confirmed via email the needle adjuster would not work.The sheath adjuster worked fine.Th 11may2017.
Additional Manufacturer Narrative
Pma/510(k) # k142688.(b)(4) exemption number: e2016031.(b)(4).1 x echo-hd-22-c from lot number c1284032 was returned to cirl for evaluation.Upon evaluation of the returned device the following was noted: the needle was fully retracted on return.There was no cracking or protrusion of the needle adjuster and it can lock in place.The sheath adjuster was cracked.The customer complaint is considered to be confirmed as cracked sheath adjuster.This initial mdr was submitted based on information received indicating this event involved the needle lock and a malfunction report was submitted based on the risk not being remote.However following the device evaluation the needle lock was confirmed to function as intended.The sheath lock was noted to be cracked and the overall risk of this failure mode is low.Therefore the fda mdr 'malfunction' reporting criteria has not been met.This follow up mdr is to cancel the initial mdr submitted.Pma/510(k) # k142688.(b)(4).Exemption number: e2016031.(b)(4).1 x echo-hd-22-c from lot number c1284032 was returned to cirl for evaluation.Upon evaluation of the returned device the following was noted: the needle was fully retracted on return.There was no cracking or protrusion of the needle adjuster and it can lock in place.The sheath adjuster was cracked.The customer complaint is considered to be confirmed as cracked sheath adjuster.This initial mdr was submitted based on information received indicating this event involved the needle lock and a malfunction report was submitted based on the risk not being remote.However following the device evaluation the needle lock was confirmed to function as intended.The sheath lock was noted to be cracked and the overall risk of this failure mode is low.Therefore the fda mdr 'malfunction' reporting criteria has not been met.This follow up mdr is to cancel the initial mdr submitted.
Event or Problem Description
This follow up cancellation mdr is being submitted as a result of the lab evaluation and overall risk was assessed as low.This initial mdr was submitted based on information received indicating this event involved the needle lock and a malfunction report was submitted based on the risk not being remote.However following the device evaluation the needle lock was confirmed to function as intended.The sheath lock was noted to be cracked and the overall risk of this failure mode is low.Therefore the fda mdr 'malfunction' reporting criteria has not been met.Initial complaint details reported as follows: as reported to customer relations: "the needle lock wouldn't work, which caused the entire needle to come out instead of desired length." district manager confirmed via email the needle adjuster would not work.The sheath adjuster worked fine.

• 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: 6590373
• Report Number: 3001845648-2017-00193
• Device Sequence Number: 613415
• Product Code: FCG
• UDI-Device Identifier: 00827002557369
• UDI-Public: (01)00827002557369(17)191013(10)C1284032
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2017

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: G55736
• Device Catalogue Number: ECHO-HD-22-C
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/01/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/01/2017
• Supplement Date Received by Manufacturer: 06/08/2017
• Initial Report FDA Received Date: 05/25/2017
• Supplement Report FDA Received Date: 07/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1