MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-11-19 for EVIS EXERA III XENON LIGHT SOURCE CLV-190 manufactured by Olympus Medical Systems Corp..
[127591743]
The user facility has stated that the device will remain at their site and will not return to olympus for evaluation. The cause of the complaint cannot be confirmed. A review of the device service history shows no olympus service since 2016. Despite followup attempts by phone and in writing, no further information is available regarding the device malfunction, mechanism of air embolism injury by the device, or type of injury. It has not been confirmed that the event involved any report of over-inflation by the device. There is also no further information on the current status of the patient. As a preventive measure against device malfunction, the instructions manual states that the device should be functionally inspected prior to the procedure, along with the other devices used. The inspection includes a verification of airflow function and verification of airflow indicators on the device. The instructions manual also warns that during the procedure,? Anytime you observe an irregularity in a light source function, stop the examination immediately.? The instructions manual notes, air and water is not fed even if the airflow indicator? On? Is lighting when no endoscope is connected to the light source.? And that the air/water function? Is available only when a compatible fiber endoscope or videoscope is connected.? The instructions manual also states,? In case of light source failure or malfunction, always keep another light source in the room ready for use.?
Patient Sequence No: 1, Text Type: N, H10
[127591744]
1 of 2. Olympus was informed that during an ercp procedure, the patient had an air embolism injury and was currently in the intensive care unit with possible compromised anatomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00707 |
| MDR Report Key | 8084443 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-19 |
| Date of Report | 2018-11-19 |
| Date of Event | 2018-10-30 |
| Date Mfgr Received | 2018-10-31 |
| Date Added to Maude | 2018-11-19 |
| 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 | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVIS EXERA III XENON LIGHT SOURCE |
| Generic Name | XENON LIGHT SOURCE |
| Product Code | GCT |
| Date Received | 2018-11-19 |
| Model Number | CLV-190 |
| Catalog Number | CLV-190 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2018-11-19 |