FDA Adverse Event
Malfunction
Summary report: N
OMNITIP SIDEFIRE STIP W/SUCTION/IRRIGATION
MDR report key: 3090822
·
Received May 2, 2013
Report
- Report Number
- 1419951-2013-00001
- Event Type
- Malfunction
- Date Received
- May 2, 2013
- Date of Event
- April 3, 2013
- Report Date
- May 2, 2013
- Manufacturer
- TRIMEDYNE, INC.
- Product Code
- GEX
- PMA / PMN Number
- K992230
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
"SURGEON WAS USING ASSEMBLED FIBER/HANDPIECE, SCRUB TECH WAS SUPPORTING FIBER ON FIELD, FIBER BURNED A HOLE IN HER (SCRUB TECH'S) DOUBLED GLOVED LEFT HAND, AND LEFT A RED MARK ON HER HAND, WITH RESIDUAL BURNING AND TINGLING. THAT FIBER BLEW OUT THE SIDE ½ THE WAY DOWN THE FIBER." THIS INFORMATION IS DOCUMENTED AS REPORTED TO TRIMEDYNE, INC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 191408 | OMNITIP SIDEFIRE STIP W/SUCTION/IRRIGATION | LASER FIBER | GEX | TRIMEDYNE, INC. | 20373-HP | 12E018 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR |