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

Model Number G34282

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The 510(k) number: k160229.(b)(4).Device evaluation: the echo-hd-25-ebus-o-c device of lot number c1238302 device involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document based investigation was conducted.Additional information was received as follows: 1.1.1 if the report involves a kink or bend in the needle, where is this located on the device (handle end or patient end)? n/a no bend/kink reported.1.1.2 please describe the location in the body for the intended target site (pancreas, stomach, etc).Lungs (probably for a lymph).1.1.3 please describe the size of the intended target site.Unknown, probably <1cm.1.1.4 what is the endoscope manufacturer and model number that was used with this device? fujinon, model unknown.1.1.5 was gaining access to the targeted site difficult? yes, needle would not extend.1.1.6 was the endoscope in a flexed or twisted position at any time during the procedure? probably not.1.1.7 was needle penetration of the targeted site difficult? yes.1.1.8 was the stylet in place inside the needle when advancing into the targeted site? yes.1.1.9 how many biopsies were obtained with use of this needle? no.1.1.10 did any section of the device detach inside the patient? no.1.1.11 was the needle fully retracted when the device was removed from the patient? yes.1.1.12 if not, with the device in question, how was the procedure performed and/or finished? removed needle from scope and used another device successfully.The complaint device underwent a laboratory evaluation on the 05th september 2018.On evaluation of the returned device it was noted that there was proximal kink possibly due to repackaging for transport returns.Needle crumpled and broke in the handle.Stylet wavy due to crumpling of needle.Syringe and adaptor was missing.Needle would not advance.Visual and functional method was used to determine the defects.Length of broken part of needle from distal side of hub measured 84mm, remainder length of needle measured 910 mm.Incorrect scope was used, as per additional information received, however this did not contribute to product failure.Complaint is confirmed as the failure was verified in the laboratory.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 breakage, thereafter causing needle advancing issue.A capa has been initiated to document and track the actions taken to investigate and to address kinking or breaking of the sheath at the sheath/sheath extender junction.The scope of the capa includes; needle breaking, kinking or crumpling within the handle assembly kinking or breaking of the sheath at the sheath/sheath extender junction.Document review: a review of the qc records did not reveal any issues which could have contributed to this complaint issue.Prior to distribution, all echo-hd-25-ebus-o-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 records for echo-hd-25-ebus-o-c device of lot number c1238302 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 #c1238302 upon review of complaints this failure mode has not occurred previously with this lot # c1238302.Ifu review: the precautions section of the instructions for use ifu0109-5 that 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.It also mentions in the precautions section; ¿when targeting multiple sites, replace device for each site.¿ there is no evidence to suggest that the customer did not follow the instructions for use (ifu0109-5).Summary: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaint is confirmed as the failure was verified in the laboratory.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

As reported to customer relations: "when placed down the scope, needle would not come out of the sheath.Removed needle from scope and used another device successfully.".

• Brand Name: ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: heather ryan ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 7929964
• MDR Text Key: 123381285
• Report Number: 3001845648-2018-00463
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002342828
• UDI-Public: (01)00827002342828(17)190603(10)C1238302
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2019
• Device Model Number: G34282
• Device Catalogue Number: ECHO-HD-25-EBUS-O-C
• Device Lot Number: C1238302
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/05/2018
• Event Location: Hospital
• Date Manufacturer Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1