FDA Adverse Event
Malfunction
Summary report: N
TX2 TISSUE REMOVAL SYSTEM - MICROTIP
MDR report key: 11653611
·
Received April 12, 2021
Report
- Report Number
- 1000135560-2021-00024
- Event Type
- Malfunction
- Date Received
- April 12, 2021
- Date of Event
- February 9, 2021
- Report Date
- April 12, 2021
- Manufacturer
- TENEX HEALTH, INC.
- Product Code
- LFL
- UDI-DI
- 00857156006154
- PMA / PMN Number
- K153299
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED AND EVALUATED. IT WAS CONFIRMED THAT THE MICROTIP NEEDLE HAD SEPARATED FROM THE REST OF THE HANDPIECE. THE FRACTURE SITE DID NOT IMMEDIATELY INDICATE A SPECIFIC CAUSE FOR THE FAILURE. TESTING AND DISASSEMBLY OF THE DEVICE DID NOT REVEAL ANY FURTHER ANOMALIES OR DEFECTS.
Description of Event or Problem · 1
DURING A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HAND PIECE. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 550640 | TX2 TISSUE REMOVAL SYSTEM - MICROTIP | INSTRUMENT, ULTRASONIC SURGICAL | LFL | TENEX HEALTH, INC. | 554-2003-001 | 3032005 | 00857156006154 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |