MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA III XENON LIGHT SOURCE

Model Number CLV-190

Device Problem Misassembly by Users (3133)

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

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated by olympus.The evaluation found that the heatsink assembly was missing.Additional evaluation findings are as follows: 1.) front panel noted broken below the scope socket and discolored; 2.) top cover slightly bent; 3.) rear panel rusted.The investigation is ongoing and the definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

An olympus, model clv-190, evis exera iii xenon light source was returned to olympus for processing with no problem reported.Upon inspection and testing of the returned unit, the lamp heatsink assembly was noted missing.This report is submitted due to the finding that the lamp heatsink assembly was missing, identified during in-house service of the device.As the problem was found during in-house service of the device, there was no patient involvement.

Manufacturer Narrative

H4 - the correct manufacture date has been confirmed and provided.This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, a definitive root cause of the missing heatsink assembly could not be identified.However, it¿s likely the cause is related to the user not attaching the heat sink when the subject device was sent to the repair site.The event can be detected/prevented by following the instructions for use which state: [important information ¿ please read before use] do not apply excessive force to the light source and/or other instruments connected.Otherwise, damage and/or malfunction can occur.[3.1 precautions for installation and connection] use the light source only under the conditions described in, "transportation, storage, and operating environments" on page 105 and, "specifications" on page 105 in the appendix.Improper performance, compromised safety and/or equipment damage may result.[7.2 storage] store the equipment at room temperature in the horizontal position in a clean, dry, and stable location.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15456300
• MDR Text Key: 306423118
• Report Number: 3002808148-2022-02199
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

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: 08/23/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2022
• Initial Date FDA Received: 09/20/2022
• Supplement Dates Manufacturer Received: 10/04/2022
• Supplement Dates FDA Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2016
• 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