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 2016-06-16 for VISERA ELITE XENON LIGHT SOURCE CLV-S190 manufactured by Olympus Medical Systems Corp..
[47488343]
The subject device has not be returned to olympus medical systems corp. For evaluation. Olympus will investigate the subject device to determine the cause of this phenomenon after olympus receives it. Olympus will submit a supplemental mdr report after the cause of this phenomenon is found.
Patient Sequence No: 1, Text Type: N, H10
[47488344]
The user was performing a radical operation of lung cancer with a thoracoscope. During a lobectomy, the examination light of the subject clv-s190 became dark. The procedure became difficult because the examination light became dark. The bleeding amount of the patient increased, because stop of the bleeding became delayed. The user completed the procedure with another similar light source. There was no report of the patient injury other than above.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2016-00771 |
| MDR Report Key | 5728285 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-06-16 |
| Date of Report | 2016-06-16 |
| Date of Event | 2016-04-11 |
| Date Mfgr Received | 2016-05-20 |
| Date Added to Maude | 2016-06-16 |
| 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. SUSUMU NISHINA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SH, TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 42 6422517 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISERA ELITE XENON LIGHT SOURCE |
| Generic Name | LIGHT SOURCE |
| Product Code | GCT |
| Date Received | 2016-06-16 |
| Model Number | CLV-S190 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-06-16 |