MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE

Catalog Number ECHO-HD-22-EBUS-O

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Blood Loss (2597)

Event Date 07/25/2019

Event Type  Injury  

Manufacturer Narrative

Common device name: fcg kit, needle, biopsy.Procode: fcg.

Event Description

As reported to customer relations "they started using an olympus needle.After using that olympus needle, they decided to use a cook needle.Toward the end, once they were done with the procedure, the patient was having some bleeding while being suctioned and cleaned up.It could not be determined which needle caused the bleeding.".

• Brand Name: ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8889106
• MDR Text Key: 154173004
• Report Number: 3005580113-2019-00243
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-HD-22-EBUS-O
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/13/2019
• Distributor Facility Aware Date: 07/26/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2019
• 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 Outcome(s): Required Intervention