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

Model Number CLV-180

Device Problem Excessive Heating (4030)

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

Event Date 06/15/2021

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report was returned to olympus.The user report was confirmed.In addition, there was deformation of the top cover, damage to the front panel, the connection scope socket was worn causes connection failure, and damage to the air pump.The legal manufacturer performed an investigation.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The root cause of the issue could not be conclusively specified.It was likely that the user installed the heat sink incorrectly (the illumination lamp and the pins on the heat sink were aligned and not securely bolted, the clamps on the heat sink were not tightened securely, or the heat sink was not securely attached).The instructions for use (ifu) provides the following guidelines and there is a possibility that this phenomenon could have been prevented: "when inserting the examination lamp into the heat sink, align their pin positions and tighten the bolts firmly.If the bolts are not tightened firmly, poor heat radiation may result in equipment damage, examination lamp ignition failure, and a considerable drop in the life of the examination lamp.If the heat sinks are not installed properly, their overheating may result in equipment damage or drop in the examination light brightness.".

Event Description

It was reported to olympus during a procedure the clv-180 evis exera ii xenon light source heat stick had burn marks on it and physical damage on the butterfly nose.There was no patient/user injury or harm reported to olympus.

• Brand Name: EVIS EXERA II 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: 12155663
• MDR Text Key: 268057510
• Report Number: 8010047-2021-08761
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170215544
• UDI-Public: 04953170215544
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/12/2021

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-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2021
• Initial Date FDA Received: 07/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2006
• 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