MAUDE Adverse Event Report: OLYMPUS OLYMPUS EVIS EXERA III; BRONCHOSCOPE

Model Number BF-1TH190

Device Problem Fire (1245)

Patient Problem Death (1802)

Event Date 06/10/2015

Event Type  Death  

Event Description

Bronchoscope in use when an airway fire occurred during use of the yag laser to ablate and upper lobe endo-bronchial tumor.Verbally reported to the manufacturer on (b)(6) 2015.

• Brand Name: OLYMPUS EVIS EXERA III
• Type of Device: BRONCHOSCOPE
• Manufacturer (Section D): OLYMPUS; 3500 corporate parkway; center valley PA 18034
• MDR Report Key: 4878121
• MDR Text Key: 21559260
• Report Number: 4878121
• Device Sequence Number: 1
• Product Code: EOQ
• 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: 06/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BF-1TH190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening
• Patient Age: 87 YR
• Patient Weight: 65