MAUDE Adverse Event Report: ICECURE MEDICAL LTD. PROSESNE CRYOPROBE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FAP7200000
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date received by manufacturer: 25-dec-2024.Device manufacture date: 17-aug-2023.
Event or Problem Description
Cryoprobe disconnected by the user.

• Brand Name: PROSESNE CRYOPROBE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): ICECURE MEDICAL LTD.; 7 haeshel st.; pob3163; caesarea,, 30795 04; IS 3079504
• Manufacturer (Section G): ICECURE MEDICAL LTD.; 7 haeshel st.; pob3163; caesarea, 30795 04; IS 3079504
• Manufacturer Contact: maayan levi ; 7 haeshel st.; pob3163; caesarea, 30795-04 ; IS 3079504
• MDR Report Key: 21187706
• Report Number: 3008797959-2025-00001
• Device Sequence Number: 12912252
• Product Code: GEH
• UDI-Device Identifier: 07290015487030
• UDI-Public: 07290015487030
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K183213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: FAP7200000
• Device Lot Number: 20230817
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2024
• Initial Report FDA Received Date: 01/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown