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

Model Number	G34281
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # k160229.Complaint device was not returned therefore a document based review will be performed.Prior to distribution, all echo-hd-22-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 (b)(4).A review of the manufacturing records for echo-hd-22-ebus-o-c of lot number c1536193 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1536193.The notes section of the instructions for use, which accompanies this device instructs the user to inspect the device prior to use for any damage: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use" and this device is intended for use with an olympus ebus scope".The answers to the additional questions confirmed that a fuji eb-530-us scope was used.As per ifu the device is intended for use with an olympus ebus scope.There is sufficient evidence to suggest that the customer did not follow the instructions for use in relation to type of scope used.A definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause may be attributed to user error, as per information provided, a fuji scope was used and as per ifu  this device is intended for use with an olympus ebus scope, therefore the user did not follow the instructions for use.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.
Event or Problem Description
The sheath detached, retracted and got stuck in the fibroscope during the procedure requiring the operator to withdraw and request another needle.The procedure couldn't be done properly as per complaint form: "problem occurred often.This day it occurred with 2 lot number: c1536193 & c1601595 the sheath detached, retracted and got stuck in t he fibroscope during the procedure requiring the operator to withdraw and request another needle.The procedure couldn't be done properly.For the 1st ebus: inability to pull the needle out of the sheath.For the second ebus: inability to remove the stylus from the needle (b)(4).".

• Brand Name: ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9231445
• Report Number: 3001845648-2019-00562
• Device Sequence Number: 388052
• Product Code: FCG
• UDI-Device Identifier: 00827002342811
• UDI-Public: (01)00827002342811(17)210904(10)C1536193
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/26/2019

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 Expiration Date: 09/04/2021
• Device Model Number: G34281
• Device Catalogue Number: ECHO-HD-22-EBUS-O-C
• Device Lot Number: C1536193
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/24/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1