FDA Adverse Event
Malfunction
Summary report: N
TX1 TISSUE REMOVAL SYSTEM- MICROTIP
MDR report key: 3670175
·
Received January 27, 2014
Report
- Report Number
- 2085033-2014-00384
- Event Type
- Malfunction
- Date Received
- January 27, 2014
- Date of Event
- August 14, 2013
- Report Date
- January 21, 2014
- Manufacturer
- AMERICAN OPTISURGICAL, INC.
- Product Code
- LFL
- PMA / PMN Number
- K123640
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UNIT WAS RECEIVED FOR EVAL. REFER TO EVAL NUMBER (B)(4) - RECEIVED WITH NO NEEDLE CAP. OBSERVED SALINE DEPOSITS ON TUBING/CASE BODY INTERFACE. PRIMED AND FUNCTIONED NORMALLY WHEN INSTALLED ON THE TEST UNIT (TEST002). COULD NOT DUPLICATE MALFUNCTION, HOWEVER, OBSERVED A FEW DROPS OF FLUID LEAKING FROM TUBING/CASE BODY INTERFACE. THE DHR FOR MICRO LOT 13413-01 WAS REVIEWED AND SHOWED THAT THE UNITS MET MFG SPECIFICATIONS WHEN RELEASED AND THERE WERE NO ISSUES RELATED TO THE COMPLAINT. (B)(4).
Description of Event or Problem · 1
PRIMING ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 58289 | TX1 TISSUE REMOVAL SYSTEM- MICROTIP | ULTRASONIC SURGICAL ASPIRATOR MGI | LFL | AMERICAN OPTISURGICAL, INC. | 13413-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |