MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA DUODENOVIDEOSCOPE

Model Number TJF-260V

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to olympus medical systems corp.(omsc) but was returned to okr for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus inspected the device at the service department of olympus (b)(4) (okr) and found that there was a gap of adhesive on the distal end of the device, and stain entered the inside of the light guide lens through the gap.Therefore, the inside of the light guide lens was dirty.There was no report of patient injury associated with this event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) confirmed that there was evidence of flooding around the light guide lens from the inspection of the device by olympus korea co., ltd (okr).Therefore, omsc determined that there was a gap in the adhesive around the light guide lens.The exact cause of the reported event could not be conclusively determined, however there is possibility that the reported event was caused by the following; -physical stress.-chemical stress.-storage environment (direct sunlight, high temperature, high humidity, environment exposed to x-rays and ultraviolet rays, etc.).-aging.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.If additional information becomes available, this report will be supplemented.

• Brand Name: EVIS LUCERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10926411
• MDR Text Key: 226948040
• Report Number: 8010047-2020-09645
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-260V
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2020
• Initial Date FDA Received: 12/01/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1