FDA Adverse Event
Malfunction
Summary report: N
TX1 TISSUE REMOVAL SYSTEM - MICROTIP
MDR report key: 3748335
·
Received January 24, 2014
Report
- Report Number
- 2085033-2014-00506
- Event Type
- Malfunction
- Date Received
- January 24, 2014
- Date of Event
- November 1, 2013
- Report Date
- January 24, 2014
- Manufacturer
- AMERICAN OPTISURGICAL, INC.
- Product Code
- LFL
- PMA / PMN Number
- K123640
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
WOULD NOT PRIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 55722 | TX1 TISSUE REMOVAL SYSTEM - MICROTIP | ULTRASONIC SURGICAL ASPIRATOR | LFL | AMERICAN OPTISURGICAL, INC. | 19713-04 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |