FDA Adverse Event
Malfunction
Summary report: N
OMNIGUIDE LASER SYSTEM
MDR report key: 3792026
·
Received April 22, 2014
Report
- Report Number
- 3792026
- Event Type
- Malfunction
- Date Received
- April 22, 2014
- Date of Event
- April 2, 2014
- Report Date
- April 22, 2014
- Manufacturer
- OMNIGUIDE INC
- Product Code
- GEX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
SURGEON BEGAN TO USE CO2 LASER. AFTER FEW MINUTES, SMELLED SOMETHING BURNED. SURGICAL TEAM INSPECTED LASER FIBER AND IT APPEARED BURNED. NO HARM TO THE PATIENT. REMOVED BURNED FIBER FROM SURGICAL FIELD; REPLACED WITH A NEW ONE. THE NEW FIBER WAS RECONNECTED TO SAME MACHINE WHICH WORKED CORRECTLY FOR FEW MINUTES AND THEN STOPPED. PANEL MESSAGE: LOW GAS FLOW. CHECKED THE TWO GAS TANKS. THEY WERE OPEN AND BOTH 75% FULL. THE FIBER DID NOT LOOK DAMAGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 243331 | OMNIGUIDE LASER SYSTEM | POWERED LASER SURGICAL INSTRUMENT | GEX | OMNIGUIDE INC | * | LA120608BB-P1 | |
| 243332 | OMNIGUIDE LASER FIBER | POWERED LASER SURGICAL INSTRUMENT | GEX | OMNIGUIDE INC | * | LA120608BB-P1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |