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

Model Number CLV-180

Device Problem Flare or Flash (2942)

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

Event Date 12/15/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, the light source front panel leds (light-emitting diodes) were blinking continuously.The issue was found during preventive maintenance and no patient was involved.There was no reports of patient harm or impact associated with this event.

Manufacturer Narrative

To date, the device has not been returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if additional information is provided by the user facility.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation and the device evaluation.Information added to the fields: d8, d9, h3, h4, and h6.The device was evaluated by olympus.The evaluation found that the allegation that the leds were blinking continuously was confirmed.Additional issues were identified during the device evaluation: the two towers with the mechanism were locked; the inside motor and reducer gears were detected to have lost grease effectiveness and have hardened.Since the device is more than 15 years old, the device history record was unable to be reviewed.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the root cause of the event could not be determined.However, it is likely that front panel illumination blinking occurred because the grease on the filter turret motor lost its effect and malfunctioned due to hardening.Olympus will continue to monitor the field performance of this device.

• Brand Name: EVIS EXERA II 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 (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18463879
• MDR Text Key: 332974730
• Report Number: 3002808148-2024-00223
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170216961
• UDI-Public: 04953170216961
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2009
• 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