MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-05-30 for LUXTEC LX300 LX300-T manufactured by Integra Luxtec, Inc..
[873446]
A luxtec light source was reported to have "visible fire and smoke, enough to set off a smoke alarm". The user also reported that none was harmed.
Patient Sequence No: 1, Text Type: D, B5
[8006159]
A luxtec light source was reported to have "visible fire and smoke, enough to set off a smoke alarm". Photo's of the light source (after the incident) were provided by the user. The photo's showed the inside of the light source and there was not only evidence of thermal damage but evidence that the light source had been significantly modified since it had been purchased. This was confirmed when the light source was received at luxtec. We did contact the original reporter of the incident and he stated the light source must have been in this modified condition since before his firm was contracted with the hospital which was 2006. Luxtec could not determine the cause of the failure due to the significant modifications made to the device. Luxtec qa/ra has retained the light source and contacted luxtec sales to work with the facility to replace the light source.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221336-2008-00002 |
| MDR Report Key | 1054631 |
| Report Source | 06 |
| Date Received | 2008-05-30 |
| Date of Report | 2008-05-30 |
| Date of Event | 2008-04-29 |
| Date Mfgr Received | 2008-05-12 |
| Device Manufacturer Date | 2005-03-15 |
| Date Added to Maude | 2009-05-04 |
| 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 | 0 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RITA WADLEIGH, DIRECTOR |
| Manufacturer Street | 99 HARTWELL STREET |
| Manufacturer City | WEST BOYLSTON MA 01583 |
| Manufacturer Country | US |
| Manufacturer Postal | 01583 |
| Manufacturer Phone | 5088359700 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUXTEC |
| Generic Name | LIGHT SOURCE |
| Product Code | EQH |
| Date Received | 2008-05-30 |
| Returned To Mfg | 2008-05-12 |
| Model Number | LX300 |
| Catalog Number | LX300-T |
| Lot Number | NA |
| Device Expiration Date | 2008-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LUXTEC, INC. |
| Manufacturer Address | 99 HARTWELL ST. WEST BOYLSTON MA 01583 US 01583 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-05-30 |