MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. 21 GAUGE EBUS NEEDLE; BRONCHOSCOPE ACCESSORY

Device Problem Failure to Obtain Sample (2533)

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

Event Date 10/05/2022

Event Type  malfunction  

Event Description

21 gauge ebus needle opened to get 5 specimens.It did not work properly.Another needle was opened from different box.That also did not work properly.Another brand different size needle was opened, and it worked well.Given to olympus rep.Manufacturer response for 21 gauge ebus needle, (brand not provided) (per site reporter) given to rep.

• Brand Name: 21 GAUGE EBUS NEEDLE
• Type of Device: BRONCHOSCOPE ACCESSORY
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 800 west park drive; westborough MA 01581
• MDR Report Key: 15657346
• MDR Text Key: 302253251
• Report Number: 15657346
• Device Sequence Number: 1
• Product Code: KTI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/11/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21900 DA
• Patient Sex: Male