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

Catalog Number	ECHO-HD-19-A
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is currently still under investigation.A follow up report will be submitted with the investigation conclusions.
Event or Problem Description
It was reported that during the use of the echotip needle, the protective sheath of the needle perforated, making it impossible to use.Consequence was a waste of time during procedure and economic consequence.
Additional Manufacturer Narrative
On evaluation of the returned device, it was noted that the needle had perforated the sheath.It was noted that the complaint description had mentioned that the physician had ¿a bad position¿; r&d engineer present commented that most likely due to this the needle perforated the sheath when trying to advance the needle.The needle could be advanced and retracted in the lab without issue.The customer complaint was confirmed as the needle had broken through the sheath.Prior to distribution, all echo-hd-19-a 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 (b)(4).A review of the manufacturing records for echo-hd-19-a devices of lot number c1078974 did not reveal any discrepancies which could have contributed to this complaint issue.From the information provided, there have been no adverse effects to the patient as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
A follow-up mdr is being submitted to include the device evaluation details and investigation conclusions.Initial complaint details: it was reported that during the use of the echotip needle, the protective sheath of the needle perforated, making it impossible to use.Consequence was a waste of time during procedure and economic consequence.
Additional Manufacturer Narrative
On evaluation of the returned device, it was noted that the needle had perforated the sheath.It was noted that the complaint description had mentioned that the physician had ¿a bad position¿; r&d engineer present commented that most likely due to this the needle perforated the sheath when trying to advance the needle.The needle could be advanced and retracted in the lab without issue.The customer complaint was confirmed as the needle had broken through the sheath.Prior to distribution, all echo-hd-19-a 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 (b)(4).A review of the manufacturing records for echo-hd-19-a devices of lot number c1078974 did not reveal any discrepancies which could have contributed to this complaint issue.From the information provided, there have been no adverse effects to the patient as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
A follow-up mdr is being submitted to correct the date aware.The device involved in this complaint was returned and evaluated on 06-jan-2017.The investigation conclusions remain unchanged.Initial complaint details: it was reported that during the use of the echotip needle, the protective sheath of the needle perforated, making it impossible to use.Consequence was a waste of time during procedure and economic consequence.

• Brand Name: ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 6188566
• Report Number: 3001845648-2016-00375
• Device Sequence Number: 708782
• Product Code: FCG
• UDI-Device Identifier: 00827002520127
• UDI-Public: (01)00827002520127(17)180205(10)C1078974
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K092359
• 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,Followup
• Report Date (Section B): 01/06/2017

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-19-A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/24/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/28/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/20/2016
• Supplement Report FDA Received Date: 01/19/2017; 02/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 59