FDA Adverse Event
Injury
Summary report: N
OMNIGUIDE LP 150
MDR report key: 1011895
·
Received March 11, 2008
Report
- Report Number
- 3005350457-2008-00002
- Event Type
- Injury
- Date Received
- March 11, 2008
- Date of Event
- February 11, 2008
- Report Date
- March 11, 2008
- Manufacturer
- OMNIGUIDE, INC.
- Product Code
- GEX
- PMA / PMN Number
- K070157
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE TRACHEAL TUBE USED TO PROVIDE VENTILATION, WAS NOT LASER SAFE. AS A RESULT, DURING THE PROCEDURE THE TRACHEAL TUBE WAS IGNITED AND CAUSED AN AIRWAY FIRE. THE PHYSICIAN WAS AWARE OF THE NEED FOR LASER SAFE EQUIPMENT AND THE REQUIREMENT IS CLEARLY DEFINED IN THE USERS' DOCUMENTATION.
Description of Event or Problem · 1
DURING LARYNGEAL AIRWAY SURGERY, AN AIRWAY FIRE OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OMNIGUIDE LP 150 | LASER WAVEGUIDE FIBER | GEX | OMNIGUIDE, INC. | LP 150 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | Life Threatening |