FDA Adverse Event
Injury
Summary report: N
PROSENSE CRYOABLATION SYSTEM
MDR report key: 18392201
·
Received December 26, 2023
Report
- Report Number
- 3008797959-2023-00014
- Event Type
- Injury
- Date Received
- December 26, 2023
- Date of Event
- January 27, 2019
- Report Date
- December 26, 2023
- Manufacturer
- ICECURE MEDICAL LTD.
- Product Code
- GEH
- PMA / PMN Number
- K183213
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
AS DETAILED ABOVE.
Description of Event or Problem · 0
INSUFFICIENT ENGULFMENT OF ELONGATED TUMOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1489065 | PROSENSE CRYOABLATION SYSTEM | UNIT, CRYOSURGICAL, ACCESSORIES | GEH | ICECURE MEDICAL LTD. | FAS3100000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other |