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

Model Number CLV-180

Device Problems Failure to Align (2522); Material Twisted/Bent (2981)

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

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 2 of 4 reports.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 importer report is to account for patient 1.

• 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: 9891491
• MDR Text Key: 194350456
• Report Number: 2951238-2020-00395
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/04/2020,03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• 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?: Yes
• Distributor Facility Aware Date: 03/03/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other