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

Model Number CLV-190

Device Problem Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned for investigation.Upon evaluation of the device, the reported issue was not confirmed.However, fluid found inside the pump system, water leaks from the output connector socket, and water leaks from the output connector were observed.The probable cause of the malfunction was, due to wear and tear damage with customer mishandling and with increasing use/time.The investigation is ongoing.Therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

A user facility reported to olympus, that an e300 error was noted with the evis exera iii xenon light source.During a standard service inspection of the customer returned device, fluid was found inside the pump system.This report is to capture the reportable malfunction found at inspection.There was no patient harm or user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to g2 and h4.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it was confirmed that water was coming from the output connector due to water leaking in the pump system.The following description is found in the instruction manual for clv-190, and this may prevent the indicated phenomenon: "before connecting the endoscope connector to the light source, confirm that the endoscope connector, including the electrical contacts, is completely dry and foreign objects such as detergent remnants, hard water residue, finger grease, dust, and lint are not on the electrical contacts.If the endoscope is used with wet and/or dirty electrical contacts, the endoscope and light source may malfunction." 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: 16771289
• MDR Text Key: 313964562
• Report Number: 3002808148-2023-03910
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/12/2023

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: 04/11/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2023
• Initial Date FDA Received: 04/19/2023
• Supplement Dates Manufacturer Received: 06/13/2023
• Supplement Dates FDA Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2016
• 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