MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE; FGE CATHETER, BILIARY, DIAGNOSTIC

Catalog Number ECHO-HD-22-EBUS-O

Device Problems Fracture (1260); Retraction Problem (1536); Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2023

Event Type  Injury  

Event Description

User detected the needle broken near handle.No needle part remain in patient.Patient outcome: "a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.".

Manufacturer Narrative

Pma/510(k) # k210476.Investigation is still pending, a follow-up mdr report will be submitted to include the investigation conclusions.

Event Description

Supplemental report being submitted due to the completion of the laboratory evaluation on 01-jun-2023 and receipt of additional information on 06-jun-2023.Additional information received as follows: at preparation stage, user found out the needle is not smoothly and difficult to retraction.User changed to another same device to complete the procedure.

Manufacturer Narrative

Pma 510k #k210476.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

Device evaluation: 1 unit of lot c1983505 of echo-hd-22-ebus-o was returned opened in its original packaging.The device related to this occurrence underwent a laboratory evaluation a proximal kink below the sheath extender was observed.No other issue was observed with the returned complaint device.Through the investigation it was established that the proximal kink which was observed during the lab evaluation was not observed prior to shipping the device back to cirl manufacturing records: prior to distribution, all echo-hd-22-ebus-o devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records for echo-hd-22-ebus-o of lot number c1983505 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use and/label: the notes section of the instructions for use, ifu0051 which 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.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0051).Image review: an image was not returned for evaluation.Root cause analysis: 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 transportation, storage facilities or handling of the packaging after the device left the manufacturing facility.This may have caused the needle to become kinked below the sheath extender which was observed during the lab evaluation but may not have been visible to the user before shipping back to cirl.This in turn may have caused the needle retraction issue during the preparation stage.Summary: complaint is confirmed based on visual and/or functional inspection.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 similar events.

Event Description

Supplement report being submitted due to the completion of the investigation 05-oct-2023.

• Brand Name: ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE
• Type of Device: FGE CATHETER, BILIARY, DIAGNOSTIC
• 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: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 17048863
• MDR Text Key: 316427624
• Report Number: 3001845648-2023-00430
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 10827002520117
• UDI-Public: (01)10827002520117(17)250929(10)C1983505
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-HD-22-EBUS-O
• Device Lot Number: C1983505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/04/2023
• Event Location: Hospital
• Date Manufacturer Received: 05/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2022
• 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