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

Model Number	G53585
Medical Device Problem Codes	Difficult to Remove (1528); Retraction Problem (1536)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2017
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.Importer site establishment registration number: 3005580113.Investigation is still pending, a follow up report will be submitted to include the investigation conclusions.
Event or Problem Description
Device was discarded.The needle stay blocked outside the sheath, while the sheath got out of the endoscope risk for the staff to get pricked.
Additional Manufacturer Narrative
510(k) number: k142688.(b)(4).Exemption number: e2016031.(b)(4).Device evaluation the echo-hd-19-c device of lot number c1396177 involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.Additional information was received and as per customer testimony the user was not injured.The customer complaint is considered to be confirmed based on customer testimony.A possible root cause could be due to difficulties experienced during the procedure because the device may have been in a torqued/flexed position or difficult target site.Documents review: a review of the qc records for qc # (b)(4) did not reveal any issues which could have contributed to this complaint issue.Prior to distribution, all echo 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 cook (b)(4).A review of the manufacturing records for this echo-hd-19-c device of lot# c1396177 revealed there were no issues which could have contributed to this complaint report.Upon review of complaints, this failure mode has not occurred previously with this lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1396177.The instructions for use, ifu0077-4, advises the user to ¿visually inspect with particular attention to kinks, bends or breaks.If an abnormality is detected that would prohibit proper working condition, do not use¿.There is no evidence to suggest that the customer did not follow the instructions for use, ifu0077-4.Summary there is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.The risk associated with this occurrence was determined to be low.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Device was discarded.The needle stay blocked outside the sheath, while the sheath got out of the endoscope risk for the staff to get pricked.

• 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: 7406794
• Report Number: 3001845648-2018-00165
• Device Sequence Number: 13739990
• Product Code: FCG
• UDI-Device Identifier: 00827002535855
• UDI-Public: (01)00827002535855(17)200904(10)C1396177
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 04/09/2018

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 Model Number: G53585
• Device Catalogue Number: ECHO-HD-19-C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/09/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 04/09/2018
• Supplement Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1