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

Model Number	G24062
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
510(k) number: k160229.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.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
When setting the adjuster on maximal extending position, sheath of the needle was still inside of the working channel (about 1,5 cm).Upon the device evaluation is was noted that the needle was broken in the handle and the needle was also crumpled in the handle.
Additional Manufacturer Narrative
510(k) number: k160229.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(4).Importer site establishment registration number: (b)(4).The echo-hd-25-ebus-o device of lot number c1340348 involved in this complaint was returned for evaluation, with the original packaging.With the information provided, a physical examination and document based investigation was conducted.As per customer testimony 1st with stylet could only be retracted with a lot of force.2nd with sheath adjuster when setting the adjuster on maximal extending position, sheath of the needle was still inside of the working channel (about 1,5 cm), on evaluation of the returned device, stylet was partially out.There was no needle exposure.Stylet was out approximately 4 cm.Needle cannot be extended, stylet cannot be inserted.The device was taken apart in the laboratory.It was noted that the needle was broken in the handle.Needle tip is intact.It was noted that needle crumpled in handle.The customer complaint is considered to be confirmed as it was found that the needle was broken within the handle assembly.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 break when attaching or detaching the device to the scope.However, as the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.It may be noted that a project (capa pr217973) has been initiated to prevent the reoccurrence of needle breaking, kinking or crumpling within the handle assembly.Document review: prior to distribution, all echo-hd-25-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 cirl.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¿.On review of the information provided, there is no viable evidence to suggest that the user did not follow the instructions for use.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0051-7).A review of the manufacturing records for echo-hd-25-ebus-o of lot number c1340348 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 # c1340348 upon review of complaints this failure mode has not occurred previously with this lot # c1340348.Summary the customer complaint is considered to be confirmed as the needle was broken within the handle assembly.The risk associated with this complaint is risk category iii/no risk level.According to the initial reporter, he patient did not require any additional procedures due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
When setting the adjuster on maximal extending position, sheath of the needle was still inside of the working channel (about 1,5 cm).Upon the device evaluation is was noted that the needle was broken in the handle and the needle was also crumpled in the handle.

• Brand Name: ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7353076
• Report Number: 3001845648-2018-00134
• Device Sequence Number: 1393308
• Product Code: FCG
• UDI-Device Identifier: 00827002240629
• UDI-Public: (01)00827002240629(17)200327(10)C1340348
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/20/2018

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: G24062
• Device Catalogue Number: ECHO-HD-25-EBUS-O
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/20/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/09/2018
• Supplement Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1