MAUDE Adverse Event Report: ICECURE MEDICAL LTD. PROSENSE CRYOABLATION SYSTEM

Model Number FAS3100000-2

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2023

Event Type  malfunction  

Event Description

Ice on the handle was reported, with no reported harm.

Manufacturer Narrative

As detailed above.

• Brand Name: PROSENSE CRYOABLATION SYSTEM
• Type of Device: PROSENSE CRYOABLATION SYSTEM
• 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: 17909451
• MDR Text Key: 326251788
• Report Number: 3008797959-2023-00008
• Device Sequence Number: 1
• Product Code: GEH
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K183213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FAS3100000-2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other