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

Model Number CLV-190

Device Problem Failure to Seal (4070)

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

Event Date 12/07/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, the light source had fluid ejected from socket that supplies air to scope.The issue was found during preparation for use for a diagnostic colonoscopy/gastroscopy procedure.The initial reporter confirmed that the intended procedure was not completed.There were no reports of patient harm.

Manufacturer Narrative

The device was returned to olympus for evaluation and the evaluation found blue liquid inside the air tubes, the scope connector socket was worn out, the front panel had traces of liquid inside near the printed circuit board, and the lamp life was over 500 hours.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.Describe cds materials, equipment and settings: the olympus disposable tubing: maj-2207 and adapter, single-patient use: maj-1652 was used, with a baxter water bottle for irrigation and lens cleaning.The gas tube: maj-1741 and unit co² regulation (ucr) for co2 insufflation.190 series endoscopes.

Event Description

The customer reports the procedure was completed, with some delay of 30minutes approximated to switch to another procedure room due was another one available.No patient under anesthesia.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following fields: d8, b5, h6, h10.Corrected fields: d10.D8 was deliberately marked.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.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 (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: 18410479
• MDR Text Key: 331693400
• Report Number: 3002808148-2023-14883
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131780
• 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

• 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: 12/11/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2017
• 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
• Treatment: MAJ-1652 AUXILIARY CHANNEL WATER TUBE.; MAJ-1741 HIGH-FLOW GAS TUBE FOR ENDOSCOPIC.; MAJ-2207 IRRIGATION TUBING WITH CO2.; UM-S20-17S: ULTRASONIC PROBE.SERIAL #: (B)(6).