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

Model Number G34785

Device Problem Retraction Problem (1536)

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

Event Date 09/12/2018

Event Type  malfunction  

Manufacturer Narrative

510 (k) number: k142688.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

The needle would not retract into the sheath; the handle was not working to retract the needle.

Manufacturer Narrative

510 (k) number: k142688.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)(6) cook medical incorporated (cmi) (b)(4).Importer site establishment registration number: (b)(4).Device evaluation: the echo-hd-3-20-c device of lot number c1488091 involved in this complaint was returned for evaluation, without original packaging.With the information provided, a physical examination and a document based investigation was conducted.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 10th october 2018.On evaluation of the returned device it was noted that there was a proximal needle breakage.Proximal end of broken needle measured 305mm from bottom of hub and 1394mm from the tip of the needle.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 device handling or excessive force was applied causing the needle breakage when attaching or dethatching the device to the scope.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: 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.The review of relevant information, confirms the failure mode of needle broken has occurred.Ifu review: the notes section of the instructions for use, ifu0077-4, 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 (ifu0077-4 ).Summary: 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.

Event Description

The needle would not retract into the sheath; the handle was not working to retract the needle.

• Brand Name: ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7955726
• MDR Text Key: 125935910
• Report Number: 3001845648-2018-00474
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002347854
• UDI-Public: (01)00827002347854(17)210525(10)C1488091
• 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: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2021
• Device Model Number: G34785
• Device Catalogue Number: ECHO-HD-3-20-C
• Device Lot Number: C1488091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/14/2018
• Event Location: Hospital
• Date Manufacturer Received: 09/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1