MAUDE Adverse Event Report: OLYMPUS AMERICA, INC. EVIA EXERA II; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number BF-Q180

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 06/15/2016

Event Type  malfunction  

Event Description

During bronchoscopy procedure preparation, white balance was performed and visualization was confirmed by viewing lettering/coloc on a tube of lidocaine jelly.Bronchoscope hung on retaining device on side of cart.Physician inserted bronchoscope through endotracheal tube then inserted past the carina.The visualization became cloudy/blurry on 90% of the screen.The only clear picture was directly at 12 o'clock.Scope removed from patient, flushed with saline and lens wiped with alcohol wipe.Picture was still cloudy/blurry.

• Brand Name: EVIA EXERA II
• Type of Device: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): OLYMPUS AMERICA, INC.; 2400 ringwood avenue; san jose, CA 95131
• MDR Report Key: 5789745
• MDR Text Key: 49426141
• Report Number: 5789745
• 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: Patient
• Type of Report: Initial
• Report Date: 06/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: BF-Q180
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/17/2016
• Event Location: Hospital
• Date Report to Manufacturer: 06/17/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ENDOTRACHEAL TUBE
• Patient Age: 62 YR