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

Model Number G55738

Device Problem Retraction Problem (1536)

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

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k142688.(b)(4).Investigation is pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

The needle was unable to move up/down.As reported by the customer: "when you unlock the dial, you physically could not move it up and down." additional information was received on 08-nov-2017 confirming: "i checked with the nurse that was doing procedures that day.She said one of the needles was able to advance but the doctor was unable to retract it.They had to pull it out of the scope with the needle still out.The other needle was unable to advance at all" this report relates to the needle that was unable to be retracted.

Manufacturer Narrative

Pma/510(k) # k142688.(b)(4).Exemption number: e2016031.Importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).Lab evaluation: the device involved in this complaint was not available for return to cook.As the device was not 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.Root cause: a possible root cause for this complaint could have been that the device was in a torqued/flexed position which led to advancement issues.Conduct wo: prior to distribution, all echo-hd-25-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-25-c device of lot# c1371787 did not reveal any discrepancies that could have contributed to this complaint issue.Ifu review: the precautions section of the instructions for use, ifu0077-4, which accompanies this device instructs the user to ensure the stylet is fully inserted when advancing the needle into the biopsy site." on review of the information provided, there is no viable evidence to suggest that the user did not follow the instructions for use.A review of the ifu shows that it has been followed.Summary: from the information provided, no adverse effects to the patient have been reported as a result of this occurrence as it was prior to use.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

The needle was unable to move up/down.As reported by the customer: "when you unlock the dial, you physically could not move it up and down." additional information was received on 08-nov-2017 confirming: "i checked with the nurse that was doing procedures that day.She said one of the needles was able to advance but the doctor was unable to retract it.They had to pull it out of the scope with the needle still out.The other needle was unable to advance at all".This report relates to the needle that was unable to be retracted.

• Brand Name: ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer Contact: michael galvin ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 7059338
• MDR Text Key: 93584513
• Report Number: 3001845648-2017-00568
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002557383
• UDI-Public: (01)00827002557383(17)200627(10)C1371787
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G55738
• Device Catalogue Number: ECHO-HD-25-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/31/2017
• Event Location: Hospital
• Date Manufacturer Received: 11/03/2017
• Date Device Manufactured: 06/27/2017
• 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