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

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 02/27/2018

Event Type  malfunction  

Event Description

During bronchoscopy, a piece of the ebus scope broke off and was inside pt's right lung.Piece was retrieved.No harm to pt.

• Brand Name: BRONCHOSCOPE
• Type of Device: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): OLYMPUS CORPORATION OF AMERICA; 3500 corporate parkway; center valley PA 18034 0610
• MDR Report Key: 7344554
• MDR Text Key: 102717010
• Report Number: MW5075882
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• 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: 66 YR