MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II XENON LIGHT SOURCE

Model Number CLV-180

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Electric Shock (2554)

Event Type  Injury  

Manufacturer Narrative

A lightsource clv-180, serial# (b)(4), was returned for evaluation.A visual inspection was performed on the received device and found a minor bend on the rear foot, and a small gap between the output socket and the front opening due to the misalignment.The light source's front panel was checked and passed all functional inspection.The device equipped with olympus xenon lamp md-631 and its light intensity reading at 310lux (brightness of lamp to be replaced 450 max).There are also no problem found with the mesh, turret runaway detection, pump pressure and scope detection.The device passed all of the electrical safety inspection.In addition, the light source was attached to a test endoscope pcf-q180al, and run for several hours, the scope¿s tip could be felt by bare hand without feeling too hot, just a warm touch.The temperature on the distal end of the endoscope was measured using a fluke 287 thermometer, and found to be around 32.2 degrees celsius, (standard <50 degrees celsius).Based on the evaluation findings, the lightsource passed the functional and electrical safety inspection.The instruction manual warns users ¿ 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.It may cause patient burns.When using manual brightness adjustment, always set the brightness to the minimum level necessary to complete the examination.If the light is too bright, eye injury or burns can result.Before connecting the endoscope connector to the light source, make sure that it is completely dry.Otherwise, electric shock or equipment damage can result.Be sure to connect the power plug of the power cord directly to a grounded wall mains outlet.If the light source is not grounded properly, it can cause an electric shock and/or fire.¿ this is to account for patient 1.This event has been reported by the importer on mdr# 2951238-2020-00395.

Event Description

The service center was informed that during a diagnostic colorectal procedure, the patient jumped and complained of a burning feeling and electricity.As a result, the patient sustained a burn.The patient¿s course of treatment is unknown.It is unknown if the intended procedure was completed.This is 1 of 4 reports.

Manufacturer Narrative

Qthis supplemental report is being submitted to report the device evaluation results.Please the updates in sections: g4, g7, h2, h3, h6 and h10.A lightsource clv-180, serial# (b)(6), equipped with 2 correct fuses t8ah250v, was returned for evaluation due to "electrical shock to patient user".A visual inspection was performed on the received device and found minor bend on the rear foot, and a small gap between the output socket and the front opening due to the misalignment.The light source's front panel was inspected and passed all functional testing.The device equipped with olympus xenon lamp md-631 and its light intensity reading at 310lux (brightness of lamp to be replaced 450 max).There was also no problem found with the turret runaway detection, pump pressure, scope detection and electrical safety inspection.(see the attached electrical safety inspection).The light source was checked with our test endoscope pcf-q180al, and ran for several hours, the scope¿s tip could be felt by bare hand without feeling too hot, just a warm touch.The temperature on the distal end of the endoscope was measured using a fluke 287 thermometer, and found to be around 32.2 degrees celsius, (standard <50 degrees celsius).Based on the evaluation findings, the lightsource passed the functional and electrical safety inspection.Per ifu, ¿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.It may cause patient burns.When using manual brightness adjustment, always set the brightness to the minimum level necessary to complete the examination.If the light is too bright, eye injury or burns can result.Before connecting the endoscope connector to the light source, make sure that it is completely dry.Otherwise, electric shock or equipment damage can result.Be sure to connect the power plug of the power cord directly to a grounded wall mains outlet.If the light source is not grounded properly, it can cause an electric shock and/or fire.¿.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Please the legal manufacturer reviewed the content of this complaint for further investigation.The legal manufacturer reported since the device was not returned the root cause could not be determined.As the results of the dhr review, it was confirmed that there was no abnormality in manufacturing, concession, and variation.The legal manufacturer reported that the most probably cause for the reported event is as follows: burn: it is assumed that the tip of the endoscope was hot and caused burns to the patient due to the following settings and handling when the malfunction was occurred.The light intensity was not used at the minimum level required for observation when manually adjusting the light intensity.The endoscope was placed close to the mucosa for a long time.Electrical shock: since there was no abnormality in the electrical safety test, it is assumed that the electric shock was not caused by the clv-180.The causes of the electric shock are assumed to be the following.·the water was remaining in the endoscope, and it was used under insufficient drying conditions.The contents of the instruction manual regarding burns are checked and the following information is included.Thus, the malfunction can be prevented.For your safety: do not touch the tip of the light-guide cable, the tip of the light-guide connector, or the output connector of the endoscope after it has been disconnected from the product.It is very hot and may cause burns.If the endoscopic image has become darker while using the endoscope, blood, mucus, or other substances may have adhered to the illuminated portion of the endoscope tip.In order to obtain adequate illuminated light and to ensure the safety of the endoscopy, it is necessary to pull the endoscope out of the patient and remove these contaminants before using it again.Continued use of the endoscope without their removal may result in increased temperature at the tip of the endoscope, which may cause damage to the patient's body and may result in burns to the patient or user.Chapter 3: inspection of usage ¿checking the manual dimming function¿.When using manual dimming, it should always be adjusted to the minimum brightness required for observation.Excessive brightness may cause eye injury or burns.When switching the brightness mode from normal to high brightness mode, be sure to set the level display below 0.If the level display is not set below 0, the brightness will be more than necessary and it may result in burns to the patient or the user.The contents of the instruction manual regarding electric shock were checked, and the following information was found.Thus, it is determined that the malfunction can be prevented.Handling and general precautions observe the following precautions.The patient or the user may receive an electric shock.Do not allow the metal parts of the endoscope or the instrument to come in contact with the metal parts of other peripheral equipment or facilities when this product is being used on a patient.There is a risk that the product may be electrically connected to the ground, causing an unintended electric current to flow to the patient.Do not pour or spill liquids such as water or other liquids on the product.If water or any other liquid gets inside this product, immediately stop using it and contact the endoscopy customer service center, the company's designated service center, or the company's branch or sales office.Do not prepare, check and use with wet hands.Do not install and use this product in the following places.Places with high oxygen concentrations.In an atmosphere of oxidizing substances such as laughing gas (n2o) where flammable anesthetic gas is used.This product is not explosion-proof, so there is a risk of explosion or fire.

• Brand Name: EVIS EXERA II 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
• MDR Report Key: 9897184
• MDR Text Key: 185790054
• Report Number: 8010047-2020-01888
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2020

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-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/30/2020
• Supplement Dates Manufacturer Received: 03/20/2020; 09/15/2020
• Supplement Dates FDA Received: 04/15/2020; 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CV-180
• Patient Outcome(s): Other