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	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the device has not yet been returned for evaluation the cause of this complaint could not be conclusively determined.With the information provided a document based investigation was carried out.The customer complaint is considered to be confirmed based on customer testimony.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 cirl.A review of the manufacturing records for echo-hd-19-a devices of lot# cf1167990 did not reveal any discrepancies that could have contributed to this complaint issue.From the information provided, ¿the patient was transferred to surgery office to treat.¿ and ¿a section of the device did not remain inside the patient¿s body.¿ complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
It was reported that the tip of needle was detached inside patient's common bile duct.They took out the detached part immediately.The patient was transferred to surgery office to treat.
Additional Manufacturer Narrative
On evaluation of the returned device, it was noted that a piece of broken needle was returned along with a device.The piece of broken needle was determined not to be from the device returned as the needle of the device returned was not broken and it could be seen that the dimpling of the piece of needle stopped before it broke and there was dimpling on the needle of the returned device also.This needle is a flat tip access needle.The customer complaint was confirmed based on customer testimony and as a broken piece of needle was returned for valuation.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# cf1167990 did not reveal any discrepancies that could have contributed to this complaint issue.From the information provided, ¿the patient was transferred to surgery office to treat.¿ and ¿a section of the device did not remain inside the patient¿s body.¿ complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
It was reported that the tip of needle was detached inside patient's common bile duct.They took out the detached part immediately.The patient was transferred to surgery office to treat.

• 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: 6224680
• Report Number: 3001845648-2017-00003
• Device Sequence Number: 13465390
• Product Code: FCG
• UDI-Device Identifier: 00827002520127
• UDI-Public: (01)00827002520127(17)181103(10)CF1167990
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K092359
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2017

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?: No
• 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: 12/07/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2017
• Supplement Report FDA Received Date: 02/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 79