MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION EVIS EXERA II; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Catalog Number PCF-Q180AL/I

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/18/2016

Event Type  malfunction  

Event Description

Colonoscope malfunctioned.

• Brand Name: EVIS EXERA II
• Type of Device: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 3500 corporate pkwy.; center valley PA 18034
• MDR Report Key: 6016812
• MDR Text Key: 56969523
• Report Number: 6016812
• 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: 03/29/2016,09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: PCF-Q180AL/I
• Device Lot Number: 2602614
• Other Device ID Number: 614
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/29/2016
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2016
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; OTHER, COLONOSCOPY
• Patient Age: 62 YR