FDA Adverse Event
Malfunction
Summary report: N
TX2 TISSUE REMOVAL SYSTEM - MICROTIP
MDR report key: 14120549
·
Received April 15, 2022
Report
- Report Number
- 1000135560-2022-00009
- Event Type
- Malfunction
- Date Received
- April 15, 2022
- Date of Event
- March 15, 2022
- Report Date
- May 18, 2022
- Manufacturer
- TENEX HEALTH, INC.
- Product Code
- LFL
- UDI-DI
- 00857156006154
- PMA / PMN Number
- K153299
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
FOLLOW-UP REPORT #01. THE DEVICE WAS RETURNED AND EVALUATED. IT WAS CONFIRMED THAT THE MICROTIP NEEDLE HAD SEPARATED FROM THE REST OF THE HANDPIECE. DUE TO THE STATE IN WHICH THE DEVICE WAS RECEIVED, FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE FRACTURE SITE DID NOT IMMEDIATELY INDICATE A SPECIFIC CAUSE FOR THE FAILURE. DISASSEMBLY OF THE DEVICE DID NOT REVEAL ANY FURTHER ANOMALIES OR DEFECTS.
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 IN TWO HANDPIECE ASSEMBLIES. THE CASE WAS COMPLETED WITH ANOTHER HANDPIECE. THERE WERE NO PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2174202 | TX2 TISSUE REMOVAL SYSTEM - MICROTIP | INSTRUMENT, ULTRASONIC SURGICAL | LFL | TENEX HEALTH, INC. | 554-2003-001 | NI | 00857156006154 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |