MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION EVIS EXERA II ULTRASONIC; BRONCHOSCOPE

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/25/2017

Event Type  malfunction  

Event Description

During endobronchial biopsy, the ebus scope and olympus tower failed.Last biopsy that was intended was not retrieved.

• Brand Name: EVIS EXERA II ULTRASONIC
• Type of Device: BRONCHOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 3500 corporate pkwy.; center valley PA 18034
• MDR Report Key: 6659910
• MDR Text Key: 78163150
• Report Number: 6659910
• 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: Other
• Type of Report: Initial
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/01/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OLYMPUS TOWER
• Patient Outcome(s): Other
• Patient Age: 60 YR