FDA Adverse Event
Malfunction
Summary report: N
PROSESNE CRYOABLATION SYSTEM
MDR report key: 19623276
·
Received June 27, 2024
Report
- Report Number
- 3008797959-2024-00010
- Event Type
- Malfunction
- Date Received
- June 27, 2024
- Date of Event
- July 6, 2023
- Report Date
- June 27, 2024
- Manufacturer
- ICECURE MEDICAL LTD.
- Product Code
- GEH
- PMA / PMN Number
- K183213
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
ERROR CODE 919 AND 4404.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 434902 | PROSESNE CRYOABLATION SYSTEM | PROSESNE CRYOABLATION SYSTEM | GEH | ICECURE MEDICAL LTD. | FAS3000000-2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |