FDA Adverse Event
Malfunction
Summary report: N
TXL TISSUE REMOVAL SYSTEM - MICROTIP
MDR report key: 3670133
·
Received January 27, 2014
Report
- Report Number
- 2085033-2014-00440
- Event Type
- Malfunction
- Date Received
- January 27, 2014
- Date of Event
- October 30, 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
- ME, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE UNIT WAS NOT RETURNED FOR EVAL. IT WAS DISPOSED OF. AN ASSIGNABLE CAUSE FOR THE UNIT FAILURE CANNOT BE VERIFIED WITHOUT EVALUATING THE ALLEGED COMPLAINT UNIT. INSUFFICIENT INFO FOR A COMPLETE INVESTIGATION. THE DHR FOR MICROTIP LOT 17013-09 WAS REVIEWED AND SHOWED THAT THE UNITS MET MFG SPECS WHEN RELEASED AND THERE WERE NO ISSUES RELATED TO THE COMPLAINT. THERE WERE 144 UNITS RELEASED FROM LOT 17013-09. (B)(4).
Description of Event or Problem · 1
NEEDLE STOPPED CUTTING AFTER 35 SEC. A TRUNK STOCK HANDPIECE WAS USED TO FINISH THE PROCEDURE. FIRST HANDPIECE WAS DISPOSED OF BY FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 58212 | TXL TISSUE REMOVAL SYSTEM - MICROTIP | ULTRASONIC SURGICAL ASPIRATOR MGI | LFL | AOI, INC. | 17013-09 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |