MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS, CORP. VIZISHOT SINGLE USE INSPIRATION NEEDLE; BRONCHOSCOPE ACCESSORY

Catalog Number NA-201SX-4021

Device Problem Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/07/2019

Event Type  malfunction  

Event Description

When you tried to advance the needle, the sheath would advance instead.Fda safety report id# (b)(4).

• Brand Name: VIZISHOT SINGLE USE INSPIRATION NEEDLE
• Type of Device: BRONCHOSCOPE ACCESSORY
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS, CORP. ; ishikawa-cho; hachioji-shi 192-8 507; JA 192-8507
• MDR Report Key: 9213627
• MDR Text Key: 163049518
• Report Number: MW5090475
• Device Sequence Number: 1
• Product Code: KTI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: NA-201SX-4021
• Device Lot Number: 91V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 104