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

Model Number TJF-260V

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned to omsc.Omsc reviewed the device history record (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, based on the information from okr, there was the possibility that this phenomenon was attributed to the excessive force, or the chemical stress, or the poor storage environment (direct sunlight, high temperature, high humidity, environment exposed to x-rays / ultraviolet rays, etc.), or the aging deterioration.

Event Description

Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair at the service department of olympus (b)(4) (okr), it was found that there was a dirt inside the light guide lens.There was no report of patient injury associated with this event.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11085335
• MDR Text Key: 227354138
• Report Number: 8010047-2020-11059
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1