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

Model Number CLV-190

Device Problem Sparking (2595)

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

Event Date 09/30/2022

Event Type  malfunction  

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 not confirmed.The unit was plugged in then tested, and no sparks were present.However, the scope socket had a faulty slider switch that was causing an intermittent use of high intensity mode.The olympus lamp life meter provided a 492+ hour reading, but had an output measured within range.There was also physical damage noted to the device.The top cover, bottom chassis, front panel, rear foot, and rear panel all had rust present.If additional information becomes available following the device evaluation, a supplemental report will be filed.

Event Description

The customer reported that her olympus evis exera iii xenon light source had sparks coming out of it during a colonoscopy procedure.According to the initial reporter, the device was inspected prior to use with no abnormalities noted.Reportedly, the procedure was completed without patient harm using another unit.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.It has been over 6 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, the reported phenomenon, ¿sparks came out (there was smell of smoke, when the plug was connected and the device was turned on, the tech saw sparks)¿, was not confirmed, and the cause of the phenomenon was not identified.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The cause of the reported event cannot be conclusively 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 Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15638488
• MDR Text Key: 306710566
• Report Number: 3002808148-2022-03370
• 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: 12/15/2022

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: 10/07/2022
• 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: 10/20/2022
• Supplement Dates Manufacturer Received: 11/25/2022
• Supplement Dates FDA Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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