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

Catalog Number ECHO-HD-22-EBUS-O

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

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

Event Date 06/13/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

User took the device out from package and detected there is a broken mark on 1.1cm from tip (pr 367848) and needle bent (pr 367849) while adjusting the needle length.No use on patient.User then changed to another same device to complete the procedure.N/a ¿ this observation was made prior to patient contact.

Manufacturer Narrative

Pma 510k # k210476.Report is being submitted as a cancellation report.Based on additional info received 19-sep-22.

Event Description

Supplement report being submitted due to the additional information received 19-sep-2022.Pr367848 was opened for the kind (kink) that observed 1.8cm from tip'.The event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.Report submitted as cancellation report.

• Brand Name: ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• 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: 15101989
• MDR Text Key: 304337290
• Report Number: 3001845648-2022-00460
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002520117
• UDI-Public: (01)10827002520117(17)250121(10)C1906279
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• 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: C1906279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/13/2022
• Event Location: Hospital
• Date Manufacturer Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2022
• 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
• Patient Age: 69 YR
• Patient Weight: 63 KG