FDA Adverse Event
Injury
Summary report: N
OMNIGUIDE BEAMPATH ENT-L
MDR report key: 2624151
·
Received September 3, 2009
Report
- Report Number
- 3005350457-2009-00003
- Event Type
- Injury
- Date Received
- September 3, 2009
- Date of Event
- August 3, 2009
- Report Date
- September 2, 2009
- Manufacturer
- OMNIGUIDE, INC.
- Product Code
- GEX
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE PATIENT WAS BEING TREATED FOR REMOVAL OF A TRACHEAL GRANULOMA. DURING THE PROCEDURE THE PHYSICIAN FIRED THE LASER HITTING THE TRACHEAL TUBE CUFF (BALLOON) CAUSING IT TO IGNITE. PER THE PHYSICIAN THE OXYGEN LEVELS WERE AT OR BELOW 30% DURING THE CASE, WHICH ARE THE RECOMMENDED LEVELS. SUBSEQUENT TO THE CASE THE LASER WAS EVALUATED BY THE HOSPITAL BIOMET AND FOUND TO BE PERFORMING TO ITS SPECIFICATION. THERE WAS NO INDICATION THAT THE FIBER MALFUNCTIONED AND IT WAS NOT RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OMNIGUIDE BEAMPATH ENT-L | CO2 WAVEGUIDE FIBER | GEX | OMNIGUIDE, INC. | ENT-L | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |