MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VISERA 4K UHD XENON LIGHT SOURCE

Model Number CLV-S400

Device Problem Excessive Heating (4030)

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

Event Date 03/28/2022

Event Type  malfunction  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

Health canada reference number (b)(4): the customer reported to health (b)(6), a burn hole was found in drapes from the light cord near patients neck.The burn hole did not penetrate deeper than drapes.No patient harm or injury reported.No additional details available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The dhr was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The case is not due to design.Based on the results of the legal manufacturer's investigation, a definitive root cause of the reported event could not be identified.The event can be detected/prevented by following the instructions for use which state: - turn the light source off or extinguish the examination lamp by pushing the lamp button while not using the light source.Leaving the examination lamp on will cause the distal end of the endoscope to become hot and could cause operator and/or patient burns.Olympus will continue to monitor field performance for this device.

• Brand Name: VISERA 4K UHD 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: 15525305
• MDR Text Key: 306503709
• Report Number: 3002808148-2022-02672
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170374579
• UDI-Public: 04953170374579
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K151011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• 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-S400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 10/01/2022
• Supplement Dates Manufacturer Received: 11/28/2022
• Supplement Dates FDA Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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