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 Problem Retraction Problem (1536)

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

Event Date 09/21/2023

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 advanced the needle device through fuji endoscope working channel to 4r location and completed first biopsy successfully.User advanced the needle device into endoscope working channel again to conduct second biopsy while found out the sheath stuck and needle retraction is diffidult.User pulled out the needle and detected the tip kink.User then retracted the needle device from endoscope and changed to another same device to complete the biopsy."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." 1.If the report involves a kink or bend in the needle, where is this located on the device (handle end or patient end)? patient end.2.Please describe the location in the body for the intended target site (pancreas, stomach, etc).Lung.3.Please describe the size of the intended target site.2.0x1.5cm 2.0x1.5.4.What is the endoscope manufacturer and model number that was used with this device? olympus bf-uc260f.Bf-uc260f.5.Was gaining access to the targeted site difficult? yes.6.Was the endoscope in a flexed or twisted position at any time during the procedure? yes.7.Was needle penetration of the targeted site difficult? no.8.Was the stylet in place inside the needle when advancing into the targeted site? yes.9.How many biopsies were obtained with use of this needle? 1.10.Did any section of the device detach inside the patient? no.11.If not with the device in question, how was the procedure performed and/or finished? with another same device to complete the procedure.

• 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: 18265217
• MDR Text Key: 329671651
• Report Number: 3001845648-2023-00884
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002520117
• UDI-Public: (01)10827002520117(17)250929(10)C1983505
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/21/2023
• Event Location: Hospital
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 60 YR
• Patient Sex: Male