MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-04-06 for OLYMPUS ACTIVE CORD MH-969 manufactured by Olympus Medical System Corporation.
[2588950]
The user facility reported that the active cord caught fire while being tested with a non-olympus electrosurgical unit (erbe) and output analyzer. The biomed at the facility reported that the purpose of the test was to check the electrosurgical unit due to user's report of the device not working correctly and having a different tone during use. There was no pt or user injury reported.
Patient Sequence No: 1, Text Type: D, B5
[9859035]
The active cord referenced in this report was returned to olympus for eval. The active cord was received in two pieces, as the cord was detached from the handpiece connector. In addition, there were evidence of tools indentations on the surface of the cable connector. There were evidence of electrical arcing and staining on the surface of the signal wires located at the detachment point. The device was forwarded to the original equipment mfr (oem) for further investigation. The exact cause of the user's experience could not be conclusively determined; however, use of a non-olympus generator or the device settings could not be ruled out as contributory factors to the reported event. This report is being submitted as a medical device in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2012-00114 |
| MDR Report Key | 2539618 |
| Report Source | 06 |
| Date Received | 2012-04-06 |
| Date of Report | 2012-03-09 |
| Date Mfgr Received | 2012-03-09 |
| Date Added to Maude | 2012-04-27 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAURA STORMS-TYLER |
| Manufacturer Street | 2400 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Manufacturer G1 | OLYMPUS MEDICAL SYSTEM CORPORATION |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 192-8507 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS ACTIVE CORD |
| Generic Name | ACTIVE CORD |
| Product Code | FFZ |
| Date Received | 2012-04-06 |
| Returned To Mfg | 2012-03-16 |
| Model Number | MH-969 |
| Catalog Number | MH-969 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEM CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-06 |