FDA Adverse Event
Malfunction
Summary report: N
TX SYSTEM - TX2 MICROTIP
MDR report key: 19602032
·
Received June 24, 2024
Report
- Report Number
- 1000135560-2024-00027
- Event Type
- Malfunction
- Date Received
- June 24, 2024
- Date of Event
- December 28, 2023
- Report Date
- June 24, 2024
- Manufacturer
- TENEX HEALTH, INC.
- Product Code
- LFL
- UDI-DI
- 00857156006154
- PMA / PMN Number
- K153299
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE INCIDENT WAS INITIALLY MISREPORTED TO TENEX HEALTH, INC. ON JANUARY 9, 2024 AS A DIFFERENT NON MDR-REPOTRABLE ISSUE. LATER COMMUNICATION WITH THE REPORTER ON JUNE 14, 2024 REVEALED THIS WAS A NEEDLE BREAK, A REPORTABLE MALFUNCTION.
Description of Event or Problem · 0
DURING A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HANDPIECE. THE PROCEDURE WAS C OMPLETED WITH ANOTHER MICROTIP. THERE WERE NO PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1019593 | TX SYSTEM - TX2 MICROTIP | INSTRUMENT, ULTRASONIC SURGICAL | LFL | TENEX HEALTH, INC. | 554-2003-001 | 2892301 | 00857156006154 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |