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

Catalog Number ECHO-1-22

Device Problems Retraction Problem (1536); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Needle was defective during use (guide wire did not progress).Please note, this file is being reported on fda precedence for non retraction of needle based on additional information received on 22-may-2020 which outlines that the needle was unable to be retracted before removing from patient.In response to question 16.Was it possible to fully retract before removing the needle from the patient? they answered 'no, it wasn¿t'.

Event Description

This is a final report.Investigation was completed on 04-sept-2020 and results and conclusions are outlined in section h of this report.Needle was defective during use (guide wire did not progress).Please note, this file is being reported on fda precedence for non retraction of needle based on additional information received on 22-may-2020 which outlines that the needle was unable to be retracted before removing from patient.In response to question 16.Was it possible to fully retract before removing the needle from the patient? they answered 'no, it wasn¿t'.

Manufacturer Narrative

Device evaluation: the echo-1-22 device of lot number c1531615 involved in this complaint was not returned for evaluation.With the limited information provided, a document based investigation was conducted.Document review including ifu review: prior to distribution, all echo-1-22 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-1-22 of lot number c1531615 did not reveal any discrepancies that could have contributed to this complaint issue.There is no evidence to suggest that this issue affects the entire lot #c1531615; upon review of complaints this failure mode has not occurred previously with this lot #c1531615.The notes section of the instructions for use, ifu0101-1 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".There is no evidence to suggest that the customer did not follow the instructions for use.From additional information provided there was no device damaged in packaging before removal and the was no damage on removal from packaging, however the kink below the sheath extender, before inserting the device into the scope was observed before use.Root cause review: a definitive root cause could not be determined from the available information.From additional information received there was a proximal kink in the needle observed there was there was a difficulty in attaching the device of the leur lock to the scope.A possible root cause could be attributed to device handling.It is possible that the kink occurred on the removal from packaging or during the device preparation, potentially causing the attachment issue (the leur lock to the scope.) however, as the device was not returned for evaluation and with limited information provided the cause of this complaint could not be conclusively determined.Summary: complaint is confirmed based on the customer¿s testimony.According to the initial reporter, 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.

• Brand Name: ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10184719
• MDR Text Key: 196924650
• Report Number: 3001845648-2020-00369
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002315188
• UDI-Public: (01)10827002315188(17)210820(10)C1531615
• Combination Product (y/n): N
• PMA/PMN Number: K083330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2021
• Device Catalogue Number: ECHO-1-22
• Device Lot Number: C1531615
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/03/2019
• Event Location: Hospital
• Date Manufacturer Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1