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	03/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
510(k) number: 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.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
As reported to customer relations, "after placing fnb needle down scope having increased difficulty extending needle into mass which did not occur with previous fna needle, able to extend into the mass located at head of pancreas at that point then had increased difficulty removing stylet throughout the whole length of stylet- unable to replace stylet into needle to process specimen, then when attempting to place needle back in scope unable to turn onto biopsy channel to lock, needle removed and another pro core fnb needle same caliber and style used without difficulty." during the lab evaluation it was noted that the needle crumpled within the handle.
Event or Problem Description
This follow up mdr is being submitted to cancel the initial report.As reported to customer relations, "after placing fnb needle down scope having increased difficulty extending needle into mass which did not occur with previous fna needle, able to extend into the mass located at head of pancreas at that point then had increased difficulty removing stylet throughout the whole length of stylet- unable to replace stylet into needle to process specimen, then when attempting to place needle back in scope unable to turn onto biopsy channel to lock, needle removed and another pro core fnb needle same caliber and style used without difficulty." during the device evaluation it was noted that the needle was crumpled in the handle.
Additional Manufacturer Narrative
510(k) number: k142688.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.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 as a cancellation report.In line with iso14971: 2012, updates were made to cirls risk management system in november 2017.These updates included the requirement to identify the initial probability of occurrence and the individual risk levels associated with each hazard and hazardous situation.As a result of the system updates the risk documentation has been revised.The severity associated with the hazardous situation has not changed however the identified risk levels associated with needle kinks on echo-hd-xx-c devices have reduced, and are now identified as presenting a low risk to the patient or end-user.This event has been re-assessed and this report is to notify the fda that this event no longer meets the fda reporting criteria of a malfunction report.No adverse effects to the patient was reported as occurring.

• 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: 7556873
• Report Number: 3001845648-2018-00253
• Device Sequence Number: 1861346
• Product Code: FCG
• UDI-Device Identifier: 00827002557383
• UDI-Public: (01)00827002557383(17)201010(10)C1408573
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2018

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 Expiration Date: 10/10/2020
• Device Model Number: G55738
• Device Catalogue Number: ECHO-HD-25-C
• Device Lot Number: C1408573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/27/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/30/2018
• Supplement Date Received by Manufacturer: 03/30/2018
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1