FDA Adverse Event
Malfunction
Summary report: N
TX2 TISSUE REMOVAL SYSTEM - MICROTIP
MDR report key: 11661519
·
Received April 13, 2021
Report
- Report Number
- 1000135560-2021-00027
- Event Type
- Malfunction
- Date Received
- April 13, 2021
- Date of Event
- March 16, 2021
- Report Date
- April 13, 2021
- Manufacturer
- TENEX HEALTH, INC.
- Product Code
- LFL
- UDI-DI
- 00857156006154
- PMA / PMN Number
- K153299
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 AND PROTRUDED FROM THE INCISION SITE. IT WAS RETRIEVED. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 559732 | TX2 TISSUE REMOVAL SYSTEM - MICROTIP | INSTRUMENT, ULTRASONIC SURGICAL | LFL | TENEX HEALTH, INC. | 554-2003-001 | 2522009 | 00857156006154 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |