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

Model Number	G55736
Medical Device Problem Codes	Bent (1059); Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2017
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 pma/510(k) # k142688 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 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 devices of lot number c1314648 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 as it was prior to use complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Upon opening user noticed that the sheath was bent and could not be used.
Additional Manufacturer Narrative
Cook (b)(4) 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).Importer site establishment registration number: 3005580113.Pma/510(k) # k142688.Additional information received on the 8th june: " i have phoned again now and the nurse said kink was identified in the packaging" 1 x echo-hd-22-c from lot number c1314648 was returned to cirl for evaluation.The evaluation of the returned device showed the following: the syringe was returned with the device and the needle was fully retracted.The conditions of the returned device would indicate that the device was removed from packaging.There was a kink noted in the needle.The needle can be advanced/retracted.The kink was approximately 84/85cm from the tip of the needle.The customer complaint is considered to be confirmed due to the kink in the needle.A possible root cause could be attributed to handling of the product when taken out of the packaging.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.The instructions for use advises the user to ¿visually inspect with particular attention to kinks, bends or breaks.If an abnormality is detected that would prohibit proper working condition, do not use¿.From the information received the patient did not experience any adverse effects due to 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
A follow up mdr is being submitted as the device was returned and evaluated.Upon opening user noticed that the sheath was bent and could not be used.

• 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: 6597675
• Report Number: 3001845648-2017-00202
• Device Sequence Number: 19103408
• Product Code: FCG
• UDI-Device Identifier: 00827002557369
• UDI-Public: (01)00827002557369(17)200112(10)C1314648
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 06/23/2017

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: G55736
• Device Catalogue Number: ECHO-HD-22-C
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/30/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/02/2017
• Supplement Date Received by Manufacturer: 06/23/2017
• Initial Report FDA Received Date: 05/30/2017
• Supplement Report FDA Received Date: 07/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1