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

Model Number CLV-190

Device Problem Corroded (1131)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The customer¿s allegation was confirmed.The device evaluation found error b30 was caused by corrosion in the socket.An additional finding found the olympus lamp replacement required due to lamp life over 500 hours.This investigation is ongoing, and a supplemental report will be submitted if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, the evis exera iii xenon light source showed error b30 during an unknown procedure.The issue was found during preparation for use.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 is likely the reported issue was caused by a faulty scope socket.It is likely fluid ingress into the scope socket contributed to the reported error code.The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu) which states the following: ¿make sure that the scope connector and its electrical contacts are completely dry and connect.If the endoscope is used with wet and/or dirty electrical contacts, the endoscope and video system center may malfunction.Clean the output socket regularly using the light source socket cleaning kit (maj-2087, optional).For details, refer to the instruction manual for the light source socket cleaning kit.If the light source is soiled, perform the following cleaning procedure immediately after use.If cleaning is delayed, residual organic debris will begin to solidify, and it may be difficult to effectively clean the light source.The light source should also be cleaned routinely.¿ 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: 16824108
• MDR Text Key: 314101278
• Report Number: 3002808148-2023-04287
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: HR
• 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
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

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: 03/28/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2023
• Initial Date FDA Received: 04/27/2023
• Supplement Dates Manufacturer Received: 05/30/2023
• Supplement Dates FDA Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2017
• 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