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

Model Number	G55736
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.However, a possible cause of this issue occurring may be due to transportation of the device or how it was stored.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-22-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 the notes section of the instructions for use, which accompanies this device instructs the user to: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".This issue was discovered prior to patient contact so there would have been no adverse effects to the patient as a result.Complaints of this nature will continue to be monitored for potential emerging trends.Other text : 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.However, a possible cause of this issue occurring may be due to transportation of the device or how it was stored.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-22-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 the notes section of the instructions for use, which accompanies this device instructs the user to: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".This issue was discovered prior to patient contact so there would have been no adverse effects to the patient as a result.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Procore 22 echo tip needle was found kinked in the box prior to use.

• 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: 6794319
• Report Number: 3001845648-2017-00337
• Device Sequence Number: 121483
• Product Code: FCG
• UDI-Device Identifier: 00827002557369
• UDI-Public: (01)00827002557369(17)190811(10)C1261371
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• 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
• Report Date (Section B): 07/18/2017

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?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/15/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 08/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1