MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-05-08 for EVIS EXERA II XENON LIGHT SOURCE CLV-180 manufactured by Olympus Medical Systems Corp..
[144398962]
The device was not returned to olympus for evaluation. The cause of the reported event cannot be determined. The clv-180 instruction manual provides users several warnings to mitigate shock. ? Before connecting the endoscope connector to the lightsource, make sure that it is completely dry. Otherwise, electric shock or equipment damage can result. Strictly observe the following precautions. Failure to do so may place the patient and medical personnel in danger of an electric shock. When the light source is used to examine a patient, do not allow metal parts of the endoscope or its accessories to touch metal parts of other system components. Such contact may cause unintended current flow to the patient. Keep fluids away from all electrical equipment. If fluids are spilled on or into the unit, stop operation of the light source immediately and contact olympus. Do not prepare, inspect or use this light source with wet. "
Patient Sequence No: 1, Text Type: N, H10
[144398963]
Olympus was informed that during or setup, the facility? S technician was shocked while connecting the gastrointestinal videoscope to the lightsource and video processor. It was reported that the video system might have been powered on but the light source was not. The user facility believes that the videoscope cable may have been connected to the light source when the incident occurred. A second technician present in the room reported observing a flash at the same time the injured technician yelled out from the shock. The technician was sent to the user facility? S emergency room and was treated for numbness in the hand. The technician is currently doing well and has since returned to full duties. Additionally, it was reported that the user facility? S biomed removed the light source and video system from service to perform a grounding and current leakage test. No anomalies were found with light source or video system. The biomed also, visually inspected the equipment and found no visible burn marks on the system. The two devices were powered by a non-olympus power source, which was also tested and inspected with no anomalies found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00818 |
| MDR Report Key | 8589628 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-05-08 |
| Date of Report | 2019-07-25 |
| Date of Event | 2019-04-03 |
| Date Mfgr Received | 2019-07-23 |
| Date Added to Maude | 2019-05-08 |
| 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 II XENON LIGHT SOURCE |
| Generic Name | XENON LIGHT SOURCE |
| Product Code | GCT |
| Date Received | 2019-05-08 |
| Returned To Mfg | 2019-06-07 |
| Model Number | CLV-180 |
| Device Availability | R |
| Device Age | DA |
| 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 | 2019-05-08 |