MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-10 for LUXTEC LX300 manufactured by Integra Lifesciences Corporation.
[64291308]
Patient Sequence No: 1, Text Type: N, H10
[64291309]
In the operating room, smoke was detected from the rear of the light source. The perfusionist and anesthesiologist unplugged the headlight from the source and unplugged the source from the wall. They wheeled it from the area near the head of the bed to the operating room door. At this time, a passing surgical tech looked into the room and was motioned to come in by the surgical team. He noted the smoke, removed the headlight source from the room and wheeled it down the hallway to an exterior patio.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6236525 |
| MDR Report Key | 6236525 |
| Date Received | 2017-01-10 |
| Date of Report | 2016-12-09 |
| Date of Event | 2016-12-05 |
| Report Date | 2016-12-09 |
| Date Reported to FDA | 2016-12-09 |
| Date Reported to Mfgr | 2016-12-09 |
| Date Added to Maude | 2017-01-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUXTEC |
| Generic Name | SOURCE, CARRIER, FIBEROPTIC LIGHT |
| Product Code | EQH |
| Date Received | 2017-01-10 |
| Model Number | LX300 |
| ID Number | CEID # 220441 |
| Device Availability | * |
| Device Age | 12 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | 311 ENTERPRISE DR. PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-10 |