FDA Adverse Event
Injury
Summary report: N
VIA360 SURGICAL SYSTEM
MDR report key: 23475775
·
Received November 5, 2025
Report
- Report Number
- 1000125279-2025-00044
- Event Type
- Injury
- Date Received
- November 5, 2025
- Report Date
- November 4, 2025
- Manufacturer
- NEW WORLD MEDICAL, INC.
- Product Code
- HMZ
- UDI-DI
- 00892064002362
- PMA / PMN Number
- K243503
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
THE IFU FOR THE REPORTED PRODUCT MODEL WAS REVIEWED AND CONFIRMED TO INCLUDE PRECAUTIONS RELATED TO HANDLING OF THE CANNULA AND MICROCATHETER, AS IMPROPER HANDLING MAY RESULT IN KINKING OR DAMAGE. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT WAS REVIEWED, AND NO ISSUES WERE IDENTIFIED. THE PRODUCT WAS MANUFACTURED, TESTED, AND RELEASED IN ACCORDANCE WITH VALIDATED PROCEDURES. THE RETURNED DEVICE WAS VISUALLY INSPECTED AND CONFIRMED TO HAVE A CUT AT THE CATHETER TIP. THE CONDITION IS CONSISTENT WITH HANDLING-RELATED DAMAGE THAT MAY OCCUR IF THE CANNULA CONTACTS OR EXERTS STRESS ON THE MICROCATHETER DURING USE.
Description of Event or Problem · 0
THE CATHETER TIP BROKE OFF IN THE CANAL DURING TRABECULOTOMY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2491425 | VIA360 SURGICAL SYSTEM | INFUSION PUMP | HMZ | NEW WORLD MEDICAL, INC. | VIA 360 | G1625 | 00892064002362 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |