MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE; FCG KIT, NEEDLE, BIOPSY

Catalog Number ECHO-25

Device Problems Break (1069); Handpiece break (1274)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/22/2013

Event Type  malfunction  

Event Description

Notification of this complaint was received directly from the fda (subject report number ((b)(4)).The complaint information was received as follows: "doctor was using the device for a fine needle aspiration during an endoscopic ultrasound.Pushed down on handle, believed it did not thread correctly and it broke.No patient injury or problem." although requested no further information has been received in relation to this complaint report.The device involved in this complaint is currently in transit to cook (b)(4).

Manufacturer Narrative

It is reasonable to assume from the initial complaint description provided that this complaint report involves a proximal needle breakage.This complaint is reportable to the fda on the basis of a previous adverse event for an echo-hd-19-c.The reporting precedence covers the entire product family.Therefore, all echo devices involving a proximal needle breakage and/or the non retraction of the needle are reportable regardless of the outcome.The device involved in this complaint has not yet been received for evaluation but is currently in transit.Upon receipt of the device a follow up report will be submitted.Notification of this complaint was received directly from the fda (subject report number (b)(4)).A possible cause of this complaint was assessed by product development engineering who determined, without reviewing the actual device, that this failure possibly occurred due to the needle crumpling within the handle.This failure could have occurred at either the proximal or distal end of the device handle.However, as the echo device involved in this complaint was not returned for evaluation it is not possible to definitively state if this is the root cause of this complaint.The relevant personnel have been notified of this complaint.The echo device involved in this complaint has not been received for evaluation therefore a document based investigation was carried out.There were no echo-25 (echo) devices of lot number c904070 in stock at the time of the complaint investigation.Prior to distribution, all echo devices are subjected to functional checks and visual inspection to ensure device integrity.A review of the manufacturing records did not reveal a discrepancy which could have contributed to the complaint issue.The complaint information received indicated that no section of the device remained inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The notes section of the instructions for use ifu0101-0 instructs the user to "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use." it was confirmed that the patient did not experience any adverse effects due to this occurrence.The risk for this complaint has been assessed and the overall risk has been determined to be low.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: tracy o'sullivan ; 61334440
• MDR Report Key: 3916527
• MDR Text Key: 18040901
• Report Number: 3001845648-2014-00039
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2016
• Device Catalogue Number: ECHO-25
• Device Lot Number: C904070
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/22/2013
• Event Location: Hospital
• Date Manufacturer Received: 02/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1