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

Model Number	G52012
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 it was originally indicated that the device involved in this complaint was being returned to cook ireland for evaluation; the device has not yet been received, however, if it is returned, the device will be evaluated and the investigation will be updated.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.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 number c1218656 did not reveal any discrepancies which could have contributed to this complaint issue.From the information received the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Problem is that needle couldn't slide correctly it was really difficult to use the stylet.They perforated the needle plastic sheath."as per complaint form": customer forget to declare the complaint end of last year 2016, they did it only in (b)(6) 2017 we don't have much details of problem, just what i described in my first email problem is that the needle couldn't slide correctly, it was very difficult to use.They perforated the plastic sheath with needle stylet no more details because it happened for a long time, dr forget this problem.No problem with patient and scope.
Additional Manufacturer Narrative
(b)(4).Exemption number: e2016031.(b)(4).1 x echo-hd-19-a was returned to cirl for evaluation upon evaluation of the returned device the following was noted: the needle was exposed from sheath on return, the needle adjuster was not secured by the thumbscrew on return so the needle could have been exposed during transport.The stylet was in place on return.The sheath was broken damaged at the tip, there was no damage to the needle tip.The sharp stylet skinned the sheath on advancing.The customer complaint is considered to be confirmed as sheath broken.A definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could not be replicated in the laboratory setting, possible causes may be due to handling of the device prior to distribution, all echo 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 from the information received the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.(b)(4).Exemption number: e2016031.(b)(4).1 x echo-hd-19-a was returned to cirl for evaluation.Upon evaluation of the returned device the following was noted: the needle was exposed from sheath on return, the needle adjuster was not secured by the thumbscrew on return so the needle could have been exposed during transport.The stylet was in place on return.The sheath was broken damaged at the tip, there was no damage to the needle tip.The sharp stylet skinned the sheath on advancing.The customer complaint is considered to be confirmed as sheath broken.A definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could not be replicated in the laboratory setting, possible causes may be due to handling of the device prior to distribution, all echo 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.From the information received the patient did not experience any adverse effects due to 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 a the device was returned and evaluated.Problem is that needle couldn't slide correctly it was really difficult to use the stylet.They perforated the needle plastic sheath."as per complaint form": customer forget to declare the complaint end of last year 2016, they did it only in (b)(6) 2017 we don't have much details of problem, just what i described in my first email problem is that the needle couldn't slide correctly, it was very difficult to use.They perforated the plastic sheath with needle stylet no more details because it happened for a long time, dr forget this problem.No problem with patient and scope.

• 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: 6571570
• Report Number: 3001845648-2017-00173
• Device Sequence Number: 10918591
• Product Code: FCG
• UDI-Device Identifier: 00827002520127
• UDI-Public: (01)00827002520127(17)190406(10)C1218656
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2017

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: G52012
• Device Catalogue Number: ECHO-HD-19-A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/17/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/19/2017
• Supplement Date Received by Manufacturer: 06/08/2017
• Initial Report FDA Received Date: 05/17/2017
• Supplement Report FDA Received Date: 07/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1