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 inspections.The device is equipped with an olympus xenon lamp md-631 with its light intensity reading at 310lux (brightness of lamp to be replaced 450 max).There are no problems found with the mesh, turret runaway detection, pump pressure or 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 report is to account for patient 2.This event has been reported by the importer on mdr# 2951238-2020-00397.

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

This 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.The legal manufacturer reviewed the content of this complaint for further investigation.The legal manufacturer reported that the root cause could not be determined.The legal manufacturer reported that the most probably cause for the reported event is the following: [burns] it is presumed that the endoscope tip became hot and resulted in burns to the patient when the device was used in setting and handling below the time of the indicated phenomenon.During manual dimming, the light intensity was not used at the minimum brightness required for observation.It has been observed close to the mucosa for a long time.[electroshock] since there were no abnormalities in the electric safety test, we speculate that it was not the generation of electric shocks caused by clv-180.It was speculated that an electric shock occurred due to the following causes: it was used in the status of insufficient drying of the endoscope.[poor appearance (with gap between output socket and front opening)] since approximately nine years and nine months have elapsed since the manufacture of this product.It was speculated that the appearance of this product was defective due to aging deterioration.

• 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: 9897529
• MDR Text Key: 195388172
• Report Number: 8010047-2020-01890
• 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: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• 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
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CV-180.
• Patient Outcome(s): Other