MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA 4K UHD XENON LIGHT SOURCE

Model Number CLV-S400

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Event Description

The customer reports during an unspecified procedure using a visera 4k uhd xenon light source, the patient sustained a burn on the inner thigh due to the light cord not being put into standby mode.No detail was provided about size/depth/severity of the burn or if any treatment/intervention was provided.The user further reports the light source on the 4k system does not default to standby mode when light cord plugs in, instead defaults to light on.Light cord remained against patients thigh in "on" mode for a short period of time prior to being connected to scope.Additional details were requested regarding the reported event.At this time no additional information has been provided.

Manufacturer Narrative

This report is being submitted to report the user's experience and the investigation findings.The suspect device was not returned to olympus for evaluation.The investigation is based on information reported by the customer.The device history record (dhr) for the device was reviewed.It was confirmed the device met all design and safety specification when shipped.The instructions for use (ifu) shipped with the device provides the user with the following information related to the reported event: do not leave the examination lamp on before and/or after inspection.The distal end temperature of the endoscope and light guide cable may rise and cause patient and/or operator injury.-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.Do not touch the endoscope¿s distal end and light guide connector while the examination lamp is lit up.The endoscope becomes hot while the examination lamp is lit up and could cause operator burn.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.Conclusion: the definitive cause of the user's experience could not be identified.Based on the investigation findings, the following was presumed: the light guide cable became hot and came into contact with the inside of the thigh because the indicated phenomenon remained the lamp lit.(facts obtained by the investigation) from the report, it was obtained the information that the patient had burned the inside of the thigh due to direct contact with the light guide cable.Clv-s400 confirmed that the light guide cable was not defaulted into the standby mode when it was inserted, but instead defaulted in lighting.Regarding burns and the burning of drapes: following the ifu would decrease the risk of the reported issue.

• Brand Name: VISERA 4K UHD XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14840120
• MDR Text Key: 294952200
• Report Number: 8010047-2022-10894
• 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,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CLV-S400
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/30/2022
• Initial Date FDA Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2019
• 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
• Patient Outcome(s): Other