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

Catalog Number	ECHO-HD-25-C
Medical Device Problem Codes	Break (1069); Retraction Problem (1536)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510k number= k142688.The device involved in this complaint is an echo-hd-25-c device of lot# c1195242 and has not been returned for evaluation.With the information provided, a document based investigation was carried out.The customer complaint is considered confirmed based on the customer testimony.A possible cause of this complaint is that the needle bent/kinked within the proximal end of the handle during use, which may be attributed to individual patient anatomy if the area being sampled was a particularly hard mass or lesion or if the endoscope was used in a tortuous anatomy.If the needle was kinked/bent during use this could result in needle breakage and preventing the needle from fully retracting into the sheath when actuating the proximal needle handle.As the device was not returned for evaluation and conditions of device usage cannot be replicated in the laboratory it is therefore not possible to conclusively determine the root cause of this complaint.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 cirl.A review of the manufacturing records for echo-hd-25-c device of lot# c1195242 did not reveal any discrepancies that could have contributed to this complaint issue.The notes section of the instructions for use ifu0077-3 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".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
While attempting to collect a sample with this device, the needle was advanced into the mass and the handle broke, therefore the needle was unable to retract.

• 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: 5586395
• Report Number: 3001845648-2016-00095
• Device Sequence Number: 278133
• Product Code: FCG
• UDI-Device Identifier: 00827002557383
• UDI-Public: (01)00827002557383(17)190126(10)C1195242
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/23/2016

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-HD-25-C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/23/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2016
• Initial Report FDA Received Date: 04/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR