MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA ELITE XENON LIGHT SOURCE

Model Number CLV-S190

Device Problem Break (1069)

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

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated at olympus (b)(4).As a result of the evaluation, the following was confirmed.There was no abnormality on the exterior of the device.Dust had accumulated inside the lamp housing.The device was soak tested for a long time of 3 days, but the error e103 did not occur.The lamp was not manufactured by olympus and the heat compound material was incorrectly applied on the positive electrode of the lamp.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 medical systems corp.(omsc) was informed by the user that during the preparation for use, clv lamp error e103 occurred.Error code e103 means that the light source has broken down.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.According to the device evaluation result, the reported event was not reproduced.However, the converter unit, igniter unit, and main board may have failed due to aging due to long-term use, and this effect may have caused clv lamp error e103 temporarily, because more than eight years have passed since the device was installed in the user facility.Alternatively, the lamp not manufactured by olympus was used, which may have caused clv lamp error e103 due to a temporary lighting failure.Since the device is a product for overseas markets, the repair history could not be confirmed.If additional information becomes available, this report will be supplemented.

• Brand Name: VISERA ELITE 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: 12286524
• MDR Text Key: 265471094
• Report Number: 8010047-2021-09897
• Device Sequence Number: 1
• Product Code: NWB
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 09/27/2021

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: No Information
• Device Model Number: CLV-S190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/15/2021
• Initial Date FDA Received: 08/06/2021
• Supplement Dates Manufacturer Received: 09/10/2021
• Supplement Dates FDA Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1