MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY

Model Number	G34785
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k)# k142688.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Prior to patient contact, the user found a needle or sheath bend of echo-hd-3-20-c/lot c1637646.Another echo-hd-3-20-c was used instead.02dec2019, (b)(6).After the first biopsy, the user removed the device from the body.When the user inserted the stylet from the hub, he felt resistance.He continued to inserting the stylet and the needle came out from the sheath tip even though the handle was locked.Therefore another echo-hd-3-20-c instead and the procedure was completed.There have been no adverse effects to the patient reported.
Event or Problem Description
Prior to patient contact, the user found a needle or sheath bend of echo-hd-3-20-c/lot c1637646.Another echo-hd-3-20-c was used instead.Additional information 02-dec-19: after the first biopsy, the user removed the device from the body.When the user inserted the stylet from the hub, he felt resistance.He continued to inserting the stylet and the needle came out from the sheath tip even though the handle was locked.Therefore another echo-hd-3-20-c instead and the procedure was completed.There have been no adverse effects to the patient reported.
Additional Manufacturer Narrative
Pma /510(k)# k142688.1 unit of lot number c1637646 of echo-hd-3-20-c was returned opened in its original packaging.The device involved in the complaint was evaluated in the laboratory.The needle was found to be broken proximally below the sheath extender.Prior to distribution, all echo-hd-3-20-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-3-20-c of lot number c1637646 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 c1637646.The notes section of the instructions for use, which accompanies this device instructs the user to inspect the device prior to use : "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.The japanese packaging insert supplied with the device complies with mhlw law no.84 of 2013 which avoids including information that is not specific to the medical device or that which is basic knowledge already understood by the healthcare professional, to ensure to accurately convey all the information that is important for the user.A definitive root cause for the customer complaint could not be determined as circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to excessive force which can be applied when trying to get the needle out of the scope during advancement, it can also be applied when removing the needle.This can lead to sheath and needle damage.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.Complaint is confirmed as the failure was verified in the laboratory.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 PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9516342
• Report Number: 3001845648-2019-00772
• Device Sequence Number: 19257276
• Product Code: FCG
• UDI-Device Identifier: 00827002347854
• UDI-Public: (01)00827002347854(17)220806(10)C1637646
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 01/30/2020

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: 08/06/2022
• Device Model Number: G34785
• Device Catalogue Number: ECHO-HD-3-20-C
• Device Lot Number: C1637646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/08/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 12/24/2019
• Supplement Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1