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

Model Number	FAP7200000
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As detailed above.
Event or Problem Description
Tip disconnection.

• Brand Name: PROSESNE CRYOPROBE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): ICECURE MEDICAL LTD.; 7 haeshel st.; pob3163; caesarea, israel 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: 20128527
• Report Number: 3008797959-2024-00012
• Device Sequence Number: 20698672
• Product Code: GEH
• UDI-Device Identifier: 07290015487030
• UDI-Public: 07290015487030
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K183213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2025

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
• Operator of Device: Health Professional
• Device Model Number: FAP7200000
• Device Lot Number: 20230817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 01/22/2025
• Date Device Manufactured: 08/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown