MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS OLYMPUS; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Lot Number 1600288

Device Problems Break (1069); Device Inoperable (1663)

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

Event Date 11/14/2017

Event Type  malfunction  

Event Description

During ultrasound bronchoscopy (ebus bronch) the scope broke.The control handle would not work.

• Brand Name: OLYMPUS
• Type of Device: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS; 2400 ringwood ave.; san jose CA 95131
• MDR Report Key: 7327013
• MDR Text Key: 101996518
• Report Number: 7327013
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 1600288
• Other Device ID Number: UC 160F-OL8-288
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/16/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1