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

Model Number G52011

Device Problems Bent (1059); Kinked (1339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k160229.(b)(4).Investigation is pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Product did not work as expected.Rep doesn't have further info.Product available in purchasing dept."as per complaint form": customer opened the package.Removed the system (ebus needle) out of the package.He tried to move the sliding sheath adjuster in-front of the endoscope.But it's not working, the sheath adjuster stuck at the system.After this he tried to remove the stylet.But it wasn't possible.He pulled harder, without success.After the third try the stylet came out of the system and was completely destroyed.The customer used a new cook set with the same lot number and the product works well.

Event Description

Product did not work as expected.Rep doesn't have further info.Product available in purchasing dept."as per complaint form": customer opened the package.Removed the system (ebus needle) out of the package.He tried to move the sliding sheath adjuster in-front of the endoscope.But it's not working, the sheath adjuster stuck at the system.After this he tried to remove the stylet.But it wasn't possible.He pulled harder, without success.After the third try the stylet came out of the system and was completely destroyed.The customer used a new cook set with the same lot number and the product works well.

Manufacturer Narrative

Pma/510(k) # k160229 (b)(4).Exemption number: e2016031 (b)(4) lab evaluation: 1 x echo-hd-22-ebus-o was returned to cook (b)(4) for evaluation.Upon evaluation, the device was returned in its original packaging and the syringe was not present upon return.The adaptor was returned along with the stylet cap which was returned in a vial.There was no needle exposure upon return.The stylet was significantly out on return.The needle could not advance and the needle was crumpled in the handle.All parts of the needle are intact.Root cause: 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.However it is possible that excessive force was applied causing the needle to crumple which led the stylet cap to come off.Documents review: prior to distribution, all echo-hd-22-ebus-o 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 cook (b)(4).Ifu review: it may be noted that according to the instructions for use, ifu0051-7, the user is instructed to: ¿visually inspect with particular attention to kinks, bends and breaks.If any abnormality is detected that would prohibit proper working condition, do not use¿.A review of the manufacturing records for echo-hd-22-ebus-o of lot number c1385717 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 # c1385717 upon review of complaints this failure mode has not occurred previously with this lot # c1385717.Summary: from the information provided, no adverse effects to the patient have been reported as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7147532
• MDR Text Key: 96218522
• Report Number: 3001845648-2017-00624
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002520110
• UDI-Public: (01)00827002520110(17)200803(10)C1385717
• Combination Product (y/n): N
• 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: 12/27/2017

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
• Device Operator: No Information
• Device Model Number: G52011
• Device Catalogue Number: ECHO-HD-22-EBUS-O
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/27/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/01/2017
• Initial Date FDA Received: 12/27/2017
• Supplement Dates Manufacturer Received: 12/01/2017
• Supplement Dates FDA Received: 01/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1