MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-07-23 for BIOLITIC SIDEFIBER ASSEMBLY, 980NM DIODE SF-980-DL manufactured by Bilitec.
[876807]
When using laser fiber and machine, a popping and sizzling sound was heard. The laser fiber became disconnected at the blue connector. Black smoke was seen on the blue connector and on the evolve machine. Emergency button was pushed and the laser machine was turned off. No flames were noted. Black residue noted on end of fiber outside of pt. Pt end with no damage. Dates of use: 2008. Diagnosis or reason for use: laser or procedure. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5007778 |
| MDR Report Key | 1081167 |
| Date Received | 2008-07-23 |
| Date of Report | 2008-07-23 |
| Date of Event | 2008-07-23 |
| Date Added to Maude | 2008-08-01 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOLITIC SIDEFIBER ASSEMBLY, 980NM DIODE |
| Generic Name | LASER FIBER |
| Product Code | LNK |
| Date Received | 2008-07-23 |
| Model Number | SF-980-DL |
| Lot Number | E08-0287-B |
| ID Number | CRM083006 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1049339 |
| Manufacturer | BILITEC |
| Manufacturer Address | 515 SHAKER ROAD EAST LONGMEADOW MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-23 |