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

Model Number CLV-S190

Device Problem Overheating of Device (1437)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 06/19/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that after the procedure involving a videoscope and a visera elite xenon light source, the socket on the light source was very hot and the nurse touched the unit and got a little burnt.Trouble shooting was performed and the issue still remained present.Additional details were requested but not provided.

Manufacturer Narrative

The device was returned and evaluated, and the customers allegations were not confirmed as they were unable to duplicate the overheating issue reported by the customer.Findings in the product evaluation were as follows: scratches on the top cover; a worn out scope socket and poor connection; the non-olympus lamp life meter was reading over 300 hours, and the light intensity output measured within range.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide additional information received from the customer through follow-up.Additional, correction to the initial with information inadvertently left out with a correction to the initial (d8).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, a specific cause of the phenomenon "the clv-s190 is getting very hot and one of the nurses touched the unit and got a little burnt" and the phenomenon "no image" could not be identified from the information received.Olympus will continue to monitor field performance for this device.

Event Description

The customer confirmed oev-262h had no image only color spots on the image.The medical assistant was setting up the scope when the problem occurred.They were removing the scope from the light source and the metal connector rod was very hot to touch and burned the user's arm when touched.The burn was very small, first degree and no treatment was required.The intended procedure was a diagnostic flexible laryngoscopy.There was a 20 minute procedural delay after troubleshooting and setting up a new scope in another room.No sedation was involved, only local anesthetic.The procedure was completed with another scope and tower equipment.There was no patient injury.Other related patient identifiers: (b)(6).

• 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: 17312329
• MDR Text Key: 319246034
• Report Number: 3002808148-2023-07036
• 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: 08/04/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 07/13/2023
• Supplement Dates FDA Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2015
• 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
• Treatment: NON-OLYMPUS LAMP