FDA Adverse Event
Malfunction
Summary report: N
PROSESNE CRYOPROBE
MDR report key: 21187706
·
Received January 19, 2025
Report
- Report Number
- 3008797959-2025-00001
- Event Type
- Malfunction
- Date Received
- January 19, 2025
- Date of Event
- December 25, 2024
- Report Date
- January 19, 2025
- Manufacturer
- ICECURE MEDICAL LTD.
- Product Code
- GEH
- UDI-DI
- 07290015487030
- PMA / PMN Number
- K183213
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
DATE RECEIVED BY MANUFACTURER: 25-DEC-2024. DEVICE MANUFACTURE DATE: 17-AUG-2023.
Description of Event or Problem · 0
CRYOPROBE DISCONNECTED BY THE USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1018012 | PROSESNE CRYOPROBE | UNIT, CRYOSURGICAL, ACCESSORIES | GEH | ICECURE MEDICAL LTD. | FAP7200000 | 20230817 | 07290015487030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |