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

Catalog Number	ECHO-HD-22-C
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/ 510k= k142688.On evaluation of the returned device, the brass insert was protruding from the sheath extension handle.The needle could be fully advanced and retracted without difficulty during the device evaluation and no issues were found with the stylet.On further inspection, no damage was noted to the needle, sheath and thumbscrew.The needle tip was examined and no damage was evident.The brass insert was noted as being orientated correctly with no visual defects.Cavity two was noted on the sheath extender.The customer complaint was confirmed as the brass insert was protruding from the sheath extension handle.However, as the conditions of device usage cannot be replicated during the laboratory evaluation, a definitive cause of this complaint could not be conclusively determined.Prior to distribution, all echo-hd-22-c 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-22-c device of lot # c1252932 did not reveal any discrepancies that could have contributed to this complaint issue.No adverse effects to the patient have been reported as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
It has been reported by the customer that the thumbscrew which is supposed to block the needle is not working.The nurse opened the package and checked needle, it was not ok.They could not adjust and fix the catheter sheath part, the wheel seemed broken.They took a second needle and no problem appeared.No problem with patient or endoscope.

• 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: 6098428
• Report Number: 3001845648-2016-00324
• Device Sequence Number: 16350550
• Product Code: FCG
• UDI-Device Identifier: 00827002557369
• UDI-Public: (01)00827002557369(17)190716(10)C1252932
• 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
• Report Date (Section B): 10/17/2016

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-22-C
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/17/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2016
• Initial Report FDA Received Date: 11/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1