MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-05 for LUXTEC HEADLIGHT SYSTEM INTEGRA MLX 300 manufactured by Integra Lifesciences Corporation.
[104444902]
Patient Sequence No: 1, Text Type: N, H10
[104444903]
It takes up to 10-15 minutes for the headlamp to illuminate. This has caused delays in care for the patient during those surgical cases. Manufacturer response for surgical head lamp, surgical headlamp (per site reporter) they are examining the light. They told us they will report this issue to the fda.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7398693 |
| MDR Report Key | 7398693 |
| Date Received | 2018-04-05 |
| Date of Report | 2018-03-26 |
| Date of Event | 2018-03-23 |
| Report Date | 2018-03-26 |
| Date Reported to FDA | 2018-03-26 |
| Date Reported to Mfgr | 2018-03-26 |
| Date Added to Maude | 2018-04-05 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 HEADLIGHT SYSTEM |
| Generic Name | LIGHT, SURGICAL, FIBEROPTIC |
| Product Code | FST |
| Date Received | 2018-04-05 |
| Returned To Mfg | 2018-03-23 |
| Model Number | INTEGRA MLX 300 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-04-05 |