MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EBUS; BIOPSY NEEDLE

Model Number NA-201SX-4022

Device Problem Defective Device (2588)

Patient Problem No Information (3190)

Event Date 07/18/2018

Event Type  malfunction  

Event Description

The wire would not thread after a few uses so they had to open another device.

• Brand Name: EBUS
• Type of Device: BIOPSY NEEDLE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 3500 corporate pkwy.; center valley PA 18034
• MDR Report Key: 7784741
• MDR Text Key: 117158636
• Report Number: 7784741
• Device Sequence Number: 1
• Product Code: FCG
• 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: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NA-201SX-4022
• Device Catalogue Number: NA201SX-4022
• Device Lot Number: 82V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1