MAUDE Adverse Event Report: ICECURE MEDICAL LTD. PROSENSE CRYOABLATION SYSTEM; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FAS3100000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Loosened pipe.

• Brand Name: PROSENSE CRYOABLATION SYSTEM
• 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: 21999793
• Report Number: 3008797959-2025-00003
• Device Sequence Number: 8641923
• Product Code: GEH
• UDI-Device Identifier: 07290015487160
• UDI-Public: 07290015487160
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: FAS3100000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 05/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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