FDA Adverse Event
Malfunction
Summary report: N
TX1 TISSUE REMOVAL SYSTEM - MICROTIP
MDR report key: 3670140
·
Received January 27, 2014
Report
- Report Number
- 2085033-2014-00430
- Event Type
- Malfunction
- Date Received
- January 27, 2014
- Date of Event
- November 1, 2013
- Report Date
- January 21, 2014
- Manufacturer
- AOI, INC.
- Product Code
- LFL
- PMA / PMN Number
- K123640
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
UNIT RECEIVED FROM THE FIELD FOR EVALUATION. REFER TO # (B)(4) - LEAKING FLUID AT CASE NOSE, CASE BODY JOINT. INSUFFICIENT SEAL AT GLUE JOINT - CAUSES UNIT TO FAIL VACUUM TEST. ON (B)(4) 2014 THE DHR FOR MICROTIP LOT 21813-01 WAS REVIEWED AND SHOWED THAT THE UNITS MET MANUFACTURING SPECIFICATIONS WHEN RELEASED AND THERE WERE NO ISSUES RELATED TO THE COMPLAINT. THERE WERE (B)(4) UNITS RELEASED FROM MICROTIP LOT #21813-01. A REVIEW OF LOT HISTORY SHOWED THAT THERE WERE TWO REPORTED MICROTIP UNIT FAILURES. THIS WAS THE FIRST REPORTED COMPLAINT OF THIS NATURE WITHIN LOT 21813-01. (B)(4).
Description of Event or Problem · 1
WATER LEAKING OUT OF BAG AND HAND DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 58269 | TX1 TISSUE REMOVAL SYSTEM - MICROTIP | ULTRASONIC SURGICAL ASPIRATOR MGI | LFL | AOI, INC. | 21813-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |