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 in this report has not been returned to olympus medical systems corp.(omsc) 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

There was a gap in the adhesive of the distal end.There was no report of patient injury associated with this event.The user facility did not provide other detailed information.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device has not been returned to olympus medical systems corp.(omsc) for evaluation, but was returned to olympus korea (okr).Okr confirmed the reported phenomenon that there was a gap in the adhesive of the distal end.In addition, okr found brown stain and traces of water ingress inside of the light guide lens, and scratches and cracks in the light guide lens.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.There was no service record for the device.The exact cause of the reported phenomenon could not be conclusively determined.However, based upon the inspection by okr, there is the possibility that this phenomenon was attributed to the physical stress or the chemical stress, the poor condition of the storage cabinet, such as environment exposed to the direct daylight, high temperature, elevated humidity, x-ray and/or ultraviolet, in the user facility, or the aging deterioration due to the long-term use, and so on.

• 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: 10910416
• MDR Text Key: 227214452
• Report Number: 8010047-2020-09506
• 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: 01/16/2021

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: 10/30/2020
• Initial Date FDA Received: 11/26/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 01/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1