MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VISERA ELITE XENON LIGHT SOURCE

Model Number CLV-S190

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 12/11/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

A customer reported to olympus that during an unknown procedure using this visera elite xenon light source, the end of the fiber optic cable burned through the drape and caused the patient to sustain a first degree burn.The burn was treated with an ointment and the procedure was completed.

Manufacturer Narrative

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 that the patient suffered a burn because the patient was positioned with the endoscope tip facing the drape while the lamp was on.Although, the root cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿do not continue observation in the proximity to tissue or keep the distal end of the endoscope in contact with living tissue for a long time.Since the light source irradiates strong examination light, the disconnected end of the light guide cable or the distal end of the endoscope becomes very hot.To prevent a fire hazard, do not bring the disconnected end of the light guide cable or distal end of the endoscope in contact with a flammable object, such as operating room drapes while the examination lamp is on.When no examination is performed, be sure to turn the light source off or extinguish the examination lamp by pushing the lamp button.¿ olympus will continue to monitor field performance for this device.

• Brand Name: VISERA ELITE 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: 16134375
• MDR Text Key: 308642300
• Report Number: 3002808148-2023-00286
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170301995
• UDI-Public: 04953170301995
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/10/2023

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-S190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/16/2022
• Initial Date FDA Received: 01/10/2023
• Supplement Dates Manufacturer Received: 02/01/2023
• Supplement Dates FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2019
• 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