FDA Adverse Event
Malfunction
Summary report: N
TYPENEX MEDICAL
MDR report key: 16206361
·
Received January 19, 2023
Report
- Report Number
- 3007336385-2023-00001
- Event Type
- Malfunction
- Date Received
- January 19, 2023
- Date of Event
- October 13, 2020
- Report Date
- October 19, 2020
- Manufacturer
- LEONI FIBER OPTICS, INC.
- Product Code
- GEX
- UDI-DI
- 00816901020470
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
DEVICE MALFUNCTION REPORTED TO TYPENEX MEDICAL WHO IN TURN NOTIFIED LEONI FIBER OPTICS, INC. CONTACT HAS BEEN MADE WITH THE DOCTOR BY TYPENEX. LEONI FIBER OPTICS, INC HAS INITIATED AN INTERNAL REVIEW. CURRENTLY WAITING FOR MORE INFORMATION.
Description of Event or Problem · 0
EVLA PROCEDURE IN THE LEFT SAPHENOUS VEIN. THIS WAS THE FIRST USE OF THIS FIBER. 15CM OF THE VEIN WERE ABLATED PRIOR TO THE FIBER FRACTURE. FIBER REMNANTS REMAIN IN THE PATIENT'S LEG. THEY ARE SEEING VASCULAR SURGERY TO ADDRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 381287 | TYPENEX MEDICAL | LASER FIBER ASSY-REUSABLE-3M LOH-HCS-.37NA 600-HARD PLASTIC CLAD-BLUE TEFZEL | GEX | LEONI FIBER OPTICS, INC. | NV0635 | J50524 | 00816901020470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |