MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORPORATION EVIS EXERA III BRONCHOVIDEOSCOPE

Model Number BF-1TH190

Device Problem Fire (1245)

Patient Problems Burn(s) (1757); Death (1802)

Event Date 06/10/2015

Event Type  Death  

Event Description

Olympus received a medwatch report #(b)(4) stating "bronchoscope in use when an airway fire occurred during the use of a yag laser to ablate an upper lobe endo-bronchial tumor." olympus followed up with the user facility to obtain additional information regarding the reported event and was informed that the event occurred during a laser bronchoscopy with ablation of a left lung tumor procedure.A fire occurred in the throat/ airway of the patient while using the device in connection with an ams laser and an aestiva anesthesia machine, the fire melted the tip of the scope about 5 inches from the distal tip.The patient was hospitalized post surgery for one day and was then transferred to the burn unit.Patient expired at the burn unit on (b)(6) 2015.It is unknown at this time what led to the patient's outcome.No additional information was provided at this time.

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation.A review of the instrument history shows that the device was purchased on 10/25/2013 and was last serviced on 02/04/2015.The exact cause of the patient's outcome could not be conclusively determined at this time.If additional information becomes available at a later time, this report will be supplemented.

• Brand Name: EVIS EXERA III BRONCHOVIDEOSCOPE
• Type of Device: EVIS EXERA III BRONCHOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORPORATION; 2951 ishikawa-cho,; hachioji-shi, tokyo,, 192- 8507; JA 192-8507
• Manufacturer Contact: noemi schambach ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355002
• MDR Report Key: 4922961
• MDR Text Key: 22036191
• Report Number: 2951238-2015-00300
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BF-1TH190
• Device Catalogue Number: BF-1TH190
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: AESTIVA ANEATHESIA MACHINE MODEL AESTIVA; CLV-190 EVIS EXERA III VIDEO XENON LIGHT SOURCE; KTP/YAG LASER: LASERSCOPE MODEL 804; CV-190 EVIS EXERA III VIDEO SYSTEM
• Patient Outcome(s): Death
• Patient Age: 87 YR
• Patient Weight: 65