FDA Adverse Event
Injury
Summary report: N
OMNIGUIDE LIGHTPATH 150
MDR report key: 1031238
·
Received April 17, 2008
Report
- Report Number
- 3005350457-2008-00003
- Event Type
- Injury
- Date Received
- April 17, 2008
- Date of Event
- January 4, 2008
- Report Date
- April 17, 2008
- Manufacturer
- OMNIGUIDE, INC.
- Product Code
- GEX
- PMA / PMN Number
- K070157
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE OMNIGUIDE SALES REPRESENTATIVE WAS NOTIFIED IN 2008 OF THIS EVENT. THE PATIENT UNDERWENT A PROCEDURE TO REMOVE TRACHEAL PAPILLOMAS WHICH WERE OCCLUDING THE AIRWAY. THE PAPILLOMAS WERE LARGE AND INITIALLY DEBULKED USING A RIGID BRONCHOSCOPE. THEY WERE THEN OBLATED USING THE OMNIGUIDE LIGHTPATH LASER FIBER. POST OPERATIVELY, THE PATIENT DEVELOPED SUB CUTANEOUS EMPHYSEMA, MOST LIKELY DUE TO TRACHEAL PERFORATION. A CHEST TUBE WAS PLACED AND THE PATIENT WAS LATER DISCHARGED. CAUSE OF THE TRACHEAL PERFORATION WAS NOT DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OMNIGUIDE LIGHTPATH 150 | LASER WAVEGUIDE FIBER | GEX | OMNIGUIDE, INC. | LP 150 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |