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

Model Number CLV-180

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 12/21/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not 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 any additional information is provided by the user facility.

Event Description

The customer reported to olympus, the evis exera ii xenon light source main lamp was blinking and made tissue indistinguishable.The light kept going in and out and started flickering.The issue was found during a diagnostic, colonoscopy procedure.There were no reports of patient harm.

Manufacturer Narrative

This supplemental report is being submitted to provide the correction of the initial mdr and the legal manufacturer's final investigation.Corrected fields: g2.Company representative was incorrectly chosen instead of health professional.Correction h10 for information inadvertently left out: the customer called olympus technical assistance center (tac).The customer confirmed the hours indicator was at 500 hours and they were having lamp failure issues.Tac emailed the clv-180 instructions for use, referred him to chapter 5 "lamp and fuse replacement" and provided the replacement lamp information.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 probable cause of the malfunction could not be identified.Three attempts were made to obtain additional information regarding the reported event, but no response was received from the customer.Olympus will continue to monitor field performance for 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: 18461487
• MDR Text Key: 332619002
• Report Number: 3002808148-2024-00217
• 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: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2023
• Initial Date FDA Received: 01/07/2024
• Supplement Dates Manufacturer Received: 02/01/2024
• Supplement Dates FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2006
• 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