MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-02-23 for VISERA XENON LIGHT SOURCE CLV-S40 manufactured by Olympus Medical Systems Cooperation.
[38853346]
Olympus checked the subject device and concomitant devices (the video processor otv-s7v and the camera head otv-s7h) at the user facility, and there was no abnormality in these devices. After that, the subject device was returned to olympus, and olympus confirmed the subject device worked properly. The user facility already sent the telescope and the light guide cable used in the procedure to smith & nephew. So olympus could not check the subject device connected with the telescope and the light guide cable. A tip of a telescope becomes hot during turning on the examination lamp of this device. The facility placed the tip of the telescope on the medical drapes while the subject device turned on, so the patient might get burned because the hot tip of the telescope touched the patient's skin via the medical drapes. Olympus also checked the device history record of the subject device, and there was no irregularity found. The instruction manual of this device already mentions cautions for a telescope and a light guide cable handling during turning on the examination lamp of this device. There were no further details provided. If significant additional information is received, this report will be supplemented. This report is being submitted as a medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[38853347]
The user facility confirmed the patient got burned and some drapes melted when the tip of the telescope contacted them during ankle arthroscopy. The user facility completed the procedure with replacing the subject device to another device. The user facility used the telescope and the light guide cable made by smith & nephew respectively in the procedure. The user facility commented they sometimes cover the tip of telescope with a swab, but they were not unsure whether they cover the tip of telescope with a swab at that time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2016-00284 |
| MDR Report Key | 5455848 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-02-23 |
| Date of Report | 2016-02-24 |
| Date of Event | 2016-01-26 |
| Date Mfgr Received | 2016-01-26 |
| Device Manufacturer Date | 2006-10-11 |
| Date Added to Maude | 2016-02-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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-SHI, 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 | 2016-02-23 |
| Model Number | CLV-S40 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS COOPERATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-23 |