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

Catalog Number ECHO-25

Device Problem Contamination (1120)

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

Event Date 05/30/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k083330.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

The needle was used once as intended with expected outcome; no issues.The dm witnessed the device was dropped on the floor by the tech.Upon attempting to use the needle for a second pass, the stylet would not advance back through the handle.The procedure was completed with another of the same device.

Manufacturer Narrative

Pma/510(k)#: k083330.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).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

The needle was used once as intended with expected outcome; no issues.The dm witnessed the device was dropped on the floor by the tech.Upon attempting to use the needle for a second pass, the stylet would not advance back through the handle.The procedure was completed with another of the same device.

Event Description

The needle was used once as intended with expected outcome; no issues.The dm witnessed the device was dropped on the floor by the tech.Upon attempting to use the needle for a second pass, the stylet would not advance back through the handle.The procedure was completed with another of the same device.

Manufacturer Narrative

Pma/510(k) # k083330.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.Complaint device was not returned therefore a document based review will be performed.It was indicated that complaint device was to be returned but has not been returned to date.If it is returned in the future then the file will be updated accordingly.Prior to distribution, all echo-25 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.As the echo-25 is from an unknown lot number, a review of the relevant manufacturing records cannot be conducted.The notes section of the instructions for use, ifu0101-0 which accompanies this device instructs the user to; "if an abnormality is detected that would prohibit proper working condition, do not use." ¿note: prior to reinserting stylet, wipe with saline or sterile water.While supporting sheath at luer lock fitting, advance stylet in small increments until stylet hub is engaged in fitting.¿ there is no evidence to suggest that the customer did not follow the instructions for use.As per medical advisor "there is a potential for infection or cross-contamination due to the device falling, the floor in theatre is not aseptic at all.It also depends on if the entire device or only the handle part dropped on the floor, the latter probably could cause less probability of infection/cross-contamination, still, i presume it was against the good clinical practice.A definitive root cause could not be determined from the available information.A possible root cause could be attributed to biological matter contained inside the needle during the procedure causing a blockage causing advancement difficulties.Complaint is confirmed based on the customer testimony.From the information provided, there were no adverse effects to the patient due to this occurrence.

• Brand Name: ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8743510
• MDR Text Key: 150146882
• Report Number: 3001845648-2019-00292
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• PMA/PMN Number: K083330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-25
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/31/2019
• Event Location: Hospital
• Date Manufacturer Received: 05/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1