MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III XENON LIGHT SOURCE

Model Number CLV-190

Device Problem Application Program Problem (2880)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

This report for non-fatal serious injury/device malfunction has been stored under the covid-19 pandemic in accordance with the guidance published by fda, postmarketing adverse event reporting for medical products and dietary supplements during a pandemic.Olympus medical systems corp.(omsc) investigated the device.However, omsc could not reproduce the reported phenomenon.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The exact cause of the reported event could not be conclusively determined.Omsc surmised that this phenomenon attributed to the temporary malfunction.If significant additional information is received, this report will be supplemented.

Event Description

The error b40 (cv malfunction error) was displayed.The user adjusted the white balance, but the endoscopic image became green.There was no report of patient injury associated with this event.The user facility did not provide other detailed information.

• Brand Name: EVIS EXERA III XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• 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: 11073407
• MDR Text Key: 228031253
• Report Number: 8010047-2020-11003
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/25/2020

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: CLV-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/08/2020
• Initial Date FDA Received: 12/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2019
• 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