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

Model Number CLV-190

Device Problem Optical Problem (3001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2021

Event Type  malfunction  

Manufacturer Narrative

While speaking with olympus technical support, the customer was instructed to change the brightness from manual to auto and reseat the communication cables between the cv-190 and clv-190.This resolved the issue.The device has not been returned and the investigation is in progress.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

It was reported to olympus, the device is very bright and washing out the image when connected to the some scopes but not the evis scope.The light source setting was manual.It was set to auto but the light is still very bright.No patient involvement.

Manufacturer Narrative

The supplemental report is submitted to provide the result of the legal manufacturer¿s investigation.The device history record for the subject device was reviewed and it was verified that the device was manufactured in accordance with documented specifications.The legal manufacturer performed an investigation.A conclusive root cause was not identified.The investigation summarized that the device had no abnormalities since the issue was resolved after the customer set the device to auto.As stated on the ifu (instruction for use) as a preventive measure, the user manual states: a description was found on brightness mode, ¿4.8 inspection of the brightness mode selection function¿, in the instruction manual.Following this inspection before use could prevent the phenomenon to occur.

• 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
• MDR Report Key: 12104999
• MDR Text Key: 263545638
• Report Number: 8010047-2021-08301
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

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: CLV-190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/03/2021
• Initial Date FDA Received: 07/01/2021
• Supplement Dates Manufacturer Received: 07/16/2021
• Supplement Dates FDA Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN SCOPES, CV190 SERIAL UNK