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 Date 03/02/2022

Event Type  Injury  

Event Description

The customer reported during a procedure, the patient was burned by the olympus device through the drape and had a blister.The light source was attached to an unknown endoscope at the time of the injury.No additional information was provided.

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.This report has been submitted by the importer under this mdr report number 2951238-2022-00365.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation and the results of the device history records (dhr) review.New information added to the following fields: h3, h4, h6, h10.The subject device was returned for evaluation.The olympus service center evaluated the device and identified the following: visual inspection as received condition found no physical damage on the appearance as everything appeared to be intact.The light source equipped with a third party brand "cermax" xenon lamp, but its lamp intensity reading is 650 lux which is adequate when checked with our osb-2 brightness checker.There are no burnt marks nor dust found inside the lamp housing.All the lenses are clean and positioned correctly on the lens base unit.However, found some stains/'spots next to power supply and on the exterior surface of the top cover vent.Further checking, noted that the customer lamp mode was originally set on high.The light source passed the turret operation check as the designated filters entered the optical path correctly.The temperature switch is functional and emergency lamp lights up properly.The scope detection, fan, dip switch setting, and main lamp on/off are all working good.In addition, the light source was checked together with our test video processor system otv-s400 together with the test camera head ch-s400.Observed that the light source auto/manual brightness adjustment are working properly.Sp high intensity and nbi mode are also functional as intended.Noted there are some light scratches on the front output socket as normal use, but the socket is still working fine.Based on the evaluation findings, the light source passed the inspection and electrical leakage safety test.In addition, a full inspection was also performed by electronics service line found brown stain/discoloration on the back of the front socket.However, the device passed functional inspection.The dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is likely due to unable to be determined.No device problem was found.As stated in the instructions for use, the event may have been prevented: regarding burns and burning of drapes, the following is stated in the instruction manual of clv-s400.·do not touch the distal end of the light guide cable or output socket of the light source immediately after disconnecting it from the light source because they are extremely hot.Operator or patient injury can result.·if the endoscopic image dims during use, blood, mucus, or debris may have soiled the light guide on the distal end of the endoscope.Carefully withdraw the endoscope from the patient and remove the blood or mucus to obtain optimum illumination and to ensure the safety of the examination.If you continue to use the endoscope in such a condition, the distal end temperature may rise and cause mucosal burns.It may also cause patient and/or operator injury.·when disconnecting the camera head from the endoscope with the examination lamp on, set the brightness mode to ¿manu¿ and set the examination light intensity to the minimum level.If the camera head is disconnected while the brightness mode is ¿auto¿, the intense light may injure your eyes.·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 use the high intensity mode when connecting to an endoscope that has an insertion tube outer diameter of 4.1 mm or less.The endoscope becomes hot while the lamp is lit up and could cause operator burn.·always adjust the examination light to the minimum required brightness for observation, and do not bring the examination light in the proximity of a mucous membrane for an extended period.Use of higher brightness than required may cause eye injury or burns to the patient.·when switching from the normal intensity mode to the high intensity mode, be sure to set the brightness indicator at or below 0.Otherwise, the brightness will exceed the necessary level.It may result in operator and/or patient injury.

• 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: 13976405
• MDR Text Key: 288377687
• Report Number: 8010047-2022-05519
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170374579
• UDI-Public: 04953170374579
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 06/10/2022

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?: Yes
• 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: 03/02/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 05/13/2022
• Supplement Dates FDA Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2021
• 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: UNKNOWN ENDOSCOPE.
• Patient Outcome(s): Other