FDA Adverse Event
Malfunction
Summary report: N
CRYOPROBE
MDR report key: 18873078
·
Received March 11, 2024
Report
- Report Number
- 3008797959-2024-00003
- Event Type
- Malfunction
- Date Received
- March 11, 2024
- Date of Event
- February 12, 2024
- Report Date
- December 15, 2024
- Manufacturer
- ICECURE MEDICAL LTD.
- Product Code
- GEH
- PMA / PMN Number
- K183213
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
AS DETAILED ABOVE.
Description of Event or Problem · 0
IRREGULAR ICE BALL SHAPE
Description of Event or Problem · 0
IRREGULAR ICE BALL SHAPE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 195277 | CRYOPROBE | UNIT, CRYOSURGICAL, ACCESSORIES | GEH | ICECURE MEDICAL LTD. | FAP7200000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |