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

Model Number CLV-190

Device Problem Image Display Error/Artifact (1304)

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

Event Type  malfunction  

Manufacturer Narrative

In speaking with the olympus technical assistance center (tac), the customer reported they had light/dark image issues in both rooms at the facility.Tac recommended the customer verify the light source cable.Only proper connection was able to be verified due to a procedure in progress.The customer also mentioned issues with the olympus 180/190 series scopes.Tac recommended verifying pigtail function and proper connection.The customer further mentioned color pars being present, but with a blank grey box in the lower corner of the screen.Tac recommended the picture in picture (pip) settings and options were initiated.The device was returned to olympus for evaluation.The device evaluation found the complaint was not confirmed and the image was displayed without noise or distortion.Evaluation did find the following: the housing had cosmetic damages (faded front panel); and the lamp had 400 or more hours.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus the evis exera iii xenon light source, had issues related to color bars and dark/light images with either of two evis exera iii video system center and another evis exera iii xenon light source.The issue occurred during preparation for use.The procedure was unknown.There were no reports of patient or user harm associated with this event.Related events: patient identifier: (b)(6), model: cv-190, serial# (b)(6).Patient identifier: (b)(6), model: cv-190, serial# (b)(6).Patient identifier: (b)(6), model: clv-190, serial# (b)(6).

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 the specific cause of phenomenon could not be identified.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: 17644485
• MDR Text Key: 322206930
• Report Number: 3002808148-2023-09124
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170304835
• UDI-Public: 04953170304835
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

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: 08/03/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: 10/06/2023
• Supplement Dates FDA Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2015
• 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