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 Type  malfunction  

Manufacturer Narrative

The unit was returned to the service center for evaluation.The customer's complaint of ¿image too dark¿ was not confirmed.The unit's front panel mouth was damaged on the housing.In addition, excessive thermal grease was noted on the unit¿s lamp body.The cause of the reported event cannot be determined at this time.The investigation of this event is ongoing and if additional information is received this report will be supplemented accordingly.

Event Description

The service center was informed that during an unspecified procedure, the image was too dark.The lamp was replaced; however, the issue was not resolved.It is unknown if the intended procedure was completed.There was no patient injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: d8, g3, g6, h2, h4, h6, and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the legal manufacturer's investigation, it is likely the application of excessive heat compound caused the picture to become darker.It is likely that the excessive heat compound was applied during lamp replacement either by the user or 3rd party repair.Though, there is no confirmation of a 3rd party repair.A review of the instruction manual identifies the following verbiage: "when replacing the examination lamp, use a clean, lint-free cloth to wipe off residual heat compound from the heat sink.If the heat compound is not wiped off completely, the lamp's heat efficiency will be impaired, and the examination lamp life will be shortened significantly".

• 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: 11733907
• MDR Text Key: 273470122
• Report Number: 8010047-2021-05493
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• PMA/PMN Number: 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: 05/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• 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: 03/31/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1