MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2016-04-26 for VISERA XENON LIGHT SOURCE CLV-S40 manufactured by Olympus Medical Systems Corp..
[43597073]
The subject device was not returned to olympus. There were no further details provided. If significant additional information is received, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[43597074]
The following event was reported in the pharmaceuticals and medical devices agency (pmda) website (url:http://www. Pmda. Go. Jp/safety/info-services/medical-safety-info/0172. Html). After the user performed the inguinal hernia surgery, the user removed edema content fluid by scrotopuncture. At that time, to confirm the location of the blood vessel in the scrotum the user connected only a light guide cable to the subject device. And the user lit up the patient's scrotum by the light guide cable. The patient got burned. The above was mentioned on the document of the web site of the pmda. (the document of the web site of the pmda: the 3rd time medical supplies, medical device and regenerative medicine are a product safe use measure consideration report of the results. The case which could think the measure of a device by a manufacturing dealer was difficult (human error and human factor). The above report does not mention that treatment of the burn was continued and failures of the subject device have occurred. Investigation result by the pmda is mentioned on the document of the web site that there is a possibility of the mistake in user's judgment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2016-00583 |
| MDR Report Key | 5606924 |
| Report Source | LITERATURE |
| Date Received | 2016-04-26 |
| Date of Report | 2016-04-26 |
| Date of Event | 2016-03-28 |
| Date Mfgr Received | 2016-03-28 |
| Date Added to Maude | 2016-04-26 |
| 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 6425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISERA XENON LIGHT SOURCE |
| Generic Name | LIGHT SOURCE |
| Product Code | GCT |
| Date Received | 2016-04-26 |
| Model Number | CLV-S40 |
| 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-SH, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2016-04-26 |