MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY

Model Number	G34279
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
510 (k) number; k160229.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.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Cook (b)(4) were informed of an incident with the echotip procore endobronchial hd ultrasound biopsy needle by (b)(6) reference# (b)(4) as follows: "we have been informed of an incident with the echotip procore endobronchial hd ultrasound biopsy needle (model echo-hd-22-ebus-p-c / g34279 ¿ lot c1527151).Incident description: broken needle.The lot number has been confirmed but the hospital / complaint facility be confirmed.Incident date not confirmed yet." we suspect this report may be a duplicate report of cook reference number (b)(4) / mdr report# 3001845648-2018-00615.We are awaiting confirmation from (b)(6).
Event or Problem Description
This cancellation follow up report is being submitted due to the confirmation that this complaint is a duplicate report of (b)(4)/ mdr report# 3001845648-2018-00615.Update from rep on (b)(6) 2019 as follows: "i have only one complaint transmitted the (b)(6) 2019 for 1 x echo-hd-22-ebus-p-c lot c1527151." federal agency for medicines and health products in belgium were in agreement.Intial report details: cook ireland were informed of an incident with the echotip procore endobronchial hd ultrasound biopsy needle by the federal agency for medicines and health productsin belgium, fagg.Be reference#(b)(4) as follows: "we have been informed of an incident with the echotip procore endobronchial hd ultrasound biopsy needle (model echo-hd-22-ebus-p-c / g34279 ¿ lot c1527151 ).Incident description: broken needle.The lot number has been confirmed but the hospital / complaint facility be confirmed.Incident date not confirmed yet." we suspect this report may be a duplicate report of cook reference number (b)(4) / mdr report# 3001845648-2018-00615.We are awaiting confirmation from federal agency for medicines and health products in belgium.
Additional Manufacturer Narrative
510 (k) number; k160229.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(4).Importer site establishment registration number: (b)(4).This cancellation follow up report is being submitted due to the confirmation that this complaint is a duplicate report of 248378 / mdr report# 3001845648-2018-00615.Update from rep on 30-jan-19 as follows: "i have only one complaint transmitted the (b)(6) 2019 for 1 x echo-hd-22-ebus-p-c lot c1527151." federal agency for medicines and health products in belgium were in agreement.This complaint file is being closed /cancelled.
Additional Manufacturer Narrative
510 (k) number; k160229.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)(6).Cook medical incorporated (cmi), 1025 acuff road, p.O box 4195, bloomington, indiana 47402-4195.Importer site establishment registration number: 3005580113.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Cook ireland were informed of an incident with the echotip procore endobronchial hd ultrasound biopsy needle by the federal agency for medicines and health products in belgium, fagg.Be reference#: (b)(4) as follows: "we have been informed of an incident with the echotip procore endobronchial hd ultrasound biopsy needle (model echo-hd-22-ebus-p-c / g34279 ¿ lot c1527151 ).Incident description: broken needle.The lot number has been confirmed but the hospital / complaint facility be confirmed.Incident date not confirmed yet." we suspect this report may be a duplicate report of cook reference number (b)(4) / mdr report# 3001845648-2018-00615.We are awaiting confirmation from federal agency for medicines and health products in belgium.

• Brand Name: ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8342335
• Report Number: 3001845648-2019-00058
• Device Sequence Number: 16623289
• Product Code: FCG
• UDI-Device Identifier: 00827002342798
• UDI-Public: (01)00827002342798(17)210803(10)C1527151
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2019

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: 08/03/2021
• Device Model Number: G34279
• Device Catalogue Number: ECHO-HD-22-EBUS-P-C
• Device Lot Number: C1527151
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/15/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 01/21/2019; 01/21/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 03/15/2019; 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1