MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-30 for EVIS EXERA II XENON LIGHT SOURCE CLV-180 manufactured by Olympus Medical Systems Corp..
[185790054]
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.
Patient Sequence No: 1, Text Type: N, H10
[185790055]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2020-01888 |
| MDR Report Key | 9897184 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR KAZUTAKA MATSUMOTO |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 426425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVIS EXERA II XENON LIGHT SOURCE |
| Generic Name | XENON LIGHT SOURCE |
| Product Code | NWB |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-06 |
| Model Number | CLV-180 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-30 |