FDA Adverse Event
Malfunction
Summary report: N
TX1 TISSUE REMOVAL SYSTEM - CONSOLE
MDR report key: 3726462
·
Received January 21, 2014
Report
- Report Number
- 2085033-2014-00242
- Event Type
- Malfunction
- Date Received
- January 21, 2014
- Date of Event
- February 25, 2013
- Report Date
- January 18, 2014
- Manufacturer
- AOI, INC.
- Product Code
- LFL
- PMA / PMN Number
- K123640
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
UNIT RECEIVED, EVALUATED BY MFG; FUNCTIONS WITHIN SPEC, FOUND S1 COMPONENT TO HAVE A BURNT CASING (OVERHEATED); REPLACED COMPONENT PER PNR# 1140; REFER TO CAPA (B)(4) FOR PHACO BOARD COMPONENT; NO COMPLAINTS SINCE THE BOARD WAS UPGRADED.
Description of Event or Problem · 1
IT STARTED TO SMOKE AND SMELLED LIKE IT WAS BURNING. THIS IS A BRAND NEW CONSOLE JUST OPENED IT UP. NEED A REPLACEMENT ASAP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 48459 | TX1 TISSUE REMOVAL SYSTEM - CONSOLE | ULTRASONIC SURGICAL ASPIRATOR MGI | LFL | AOI, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |