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

Model Number	G55738
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # k142688.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Investigation is pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7059338
• Report Number: 3001845648-2017-00568
• Device Sequence Number: 1824374
• Product Code: FCG
• UDI-Device Identifier: 00827002557383
• UDI-Public: (01)00827002557383(17)200627(10)C1371787
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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
• Report Date (Section B): 11/27/2017

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 Model Number: G55738
• Device Catalogue Number: ECHO-HD-25-C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/31/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/03/2017
• Supplement Date Received by Manufacturer: 11/03/2017
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1