MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-04 for FORNISEE SYSTEM FS-40 manufactured by Lsi Solutions , Inc..
[177634294]
At 1500, md stated that light source for the fornisee system was smoking. Light source was not connected at that moment to the fornisee system. Immediately the light source was turned off. Light cord removed and device removed from the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9665389 |
| MDR Report Key | 9665389 |
| Date Received | 2020-02-04 |
| Date of Report | 2019-12-03 |
| Date of Event | 2019-11-25 |
| Report Date | 2019-12-03 |
| Date Reported to FDA | 2019-12-03 |
| Date Reported to Mfgr | 2020-02-04 |
| Date Added to Maude | 2020-02-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | FORNISEE SYSTEM |
| Generic Name | CULDOSCOPE (AND ACCESSORIES) |
| Product Code | HEW |
| Date Received | 2020-02-04 |
| Model Number | FS-40 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LSI SOLUTIONS , INC. |
| Manufacturer Address | 7796 VICTOR-MENDON RD VICTOR NY 14564 US 14564 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-04 |