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

Model Number CLV-190

Device Problem Mechanical Jam (2983)

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

Event Date 09/29/2022

Event Type  malfunction  

Event Description

The customer reported that her olympus evis exera iii xenon light source¿s power button would not stay latched during an unspecified procedure.Additional information was requested from the initial reporter; however, all other details were unknown.She could only confirm that the patient¿s outcome was unaffected by the reported event.

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user¿s report was confirmed.A faulty harness switch was discovered and caused the reported failure.Additionally, the bottom chassis and front panel chassis both had rust present.Other cosmetic damage was noted on the device, but those did not impact the functionality of the unit.If additional information becomes available following the device evaluation, a supplemental report will be filed.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.It has been over 8 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, it was determined that the power switch did not remain pushed in due to faulty harness switch.It was recommended to replace the harness switch.A review of the device history record found no deviations that could have caused or contributed to the reported issue.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 Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15651714
• MDR Text Key: 306644203
• Report Number: 3002808148-2022-03425
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2022

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: 10/11/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/21/2022
• Supplement Dates Manufacturer Received: 11/25/2022
• Supplement Dates FDA Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2014
• 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