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

Model Number CLV-190

Device Problem Wireless Communication Problem (3283)

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

Event Date 11/23/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned and evaluated.The evaluation confirmed the reported e315 error code.A rusty socket unit, likely caused by fluid invasion, was thought to have contributed to the production of this error code.The reported b30 error code was not confirmed however.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus during preparation for use, b30 and e315 (scope communication error) codes displayed on the monitor when the gastroscope was connected to evis exera iii xenon light source.Another similar device used to complete the diagnostic procedure.There were no reports of patient harm associated with this event.This is report #1 of 2 due to multiple events reported.Reference report patient identifiers (b)(6) and (b)(6) for additional events reported.

Event Description

The customer reported to olympus during preparation for a diagnostic endoscopy, a b30(scope communication error).The procedure was continued and completed with other system (hospital has more systems those are used for back-up).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation, device history record review and additional information provided by the customer.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The exact root cause could not be determined.The investigation determined rust was found on the scope connector.Thus, b30 might have occurred due to contact failure.The cause of the fault could not be identified since further information was not available.Olympus will continue to monitor the field performance of 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: 16040124
• MDR Text Key: 308466101
• Report Number: 3002808148-2022-05545
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/23/2023

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: 11/24/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/23/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 12/25/2022
• Supplement Dates FDA Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2016
• 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
• Treatment: VIDEO SYSTEM CENTER.MONITOR.GASTROSCOPE.