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

Catalog Number	ECHO-HD-19-C
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # k142688.The complaint device is awaiting return to cirl for evaluation.On return of the device a lab evaluation will be carried out and the investigation updated.The customer complaint is confirmed based on the customer testimony.As the device is awaiting return for evaluation, it is therefore not possible to conclusively determine the root cause of this complaint.With the information provided, a document based investigation was carried out.Prior to distribution, all echo-hd-19-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 record for echo-hd-19-c device of lot number c1096235 did not reveal any discrepancies which could have contributed to this complaint report.From the information provided, there have been no adverse effects to the patient as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
The user punctured the ultrasound biopsy needle into pelvic tumor and began to pull back.The needle failed to pull back to biopsy.The device was withdrawn from the endoscope.The device was examined and about 1.5cm of the distal tip of needle was bent.Then user tried to retract needle into sheath.Tip of needle was detached.The sheath reference mark could not be adjusted at 0 mark.Replace new device to finish the procedure.No adverse event effects.
Additional Manufacturer Narrative
Pma/510(k) # k142688.On evaluation of the returned device, it was noted that the needle was broken 1.5cm from the tip approximately.The rest of the needle advanced and retracted fine.The stylet was in place on return.The customer complaint was confirmed as the needle was broken.Prior to distribution, all echo-hd-19-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 record for echo-hd-19-c device of lot number c1096235 did not reveal any discrepancies which could have contributed to this complaint report.From the information provided, there have been no adverse effects to the patient as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
This follow up is being submitted due to receipt and evaluation of the device.The user punctured the ultrasound biopsy needle into pelvic tumor and began to pull back.The needle failed to pull back to biopsy.The device was withdrawn from the endoscope.The device was examined and about 1.5cm of the distal tip of needle was bent.Then user tried to retract needle into sheath.Tip of needle was detached.The sheath reference mark could not be adjusted at 0 mark.Replace new device to finish the procedure.No adverse event effects.

• 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: 6184977
• Report Number: 3001845648-2016-00370
• Device Sequence Number: 90104
• Product Code: FCG
• UDI-Device Identifier: 00827002535855
• UDI-Public: (01)00827002535855(17)180328(10)C1096235
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 01/06/2017

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 Catalogue Number: ECHO-HD-19-C
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/15/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2016
• Supplement Report FDA Received Date: 02/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 56