FDA Adverse Event
Malfunction
Summary report: N
TX1 TISSUE REMOVAL SYSTEM - MIEROTIP
MDR report key: 3670144
·
Received January 27, 2014
Report
- Report Number
- 2085033-2014-00422
- Event Type
- Malfunction
- Date Received
- January 27, 2014
- Date of Event
- October 18, 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
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE PROCTOR MISTAKENLY DISCARDED THE HANDPIECE. IT IS NOT POSSIBLE TO VERIFY AN ASSIGNABLE CAUSE WITHOUT EVALUATING THE ALLEGED COMPLAINT UNIT. INSUFFICIENT INFORMATION FOR A COMPLETE INVESTIGATION. THE DHR FOR MICROTIP LOT 20713-06 WAS REVIEWED AND SHOWED THAT THE UNITS MET MANUFACTURING SPECIFICATIONS WHEN RELEASED AND THERE WERE NO ISSUES RELATED TO THE COMPLAINT. (B)(4).
Description of Event or Problem · 1
HEADPIECE SPRAING A LEAK WHILE PRIMING. THE LEAK WAS NEAR THE HANDLE. (B)(6) WAS IN ATTENDANCE AT THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 58219 | TX1 TISSUE REMOVAL SYSTEM - MIEROTIP | ULTRASONIC SURGICAL ASPIRARRY | LFL | AMERICAN OPTISURGICAL, INC. | 20713-06 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |