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

Model Number FAS3100000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Urinary Tract Infection (2120); Hematuria (2558)

Event Date 04/19/2018

Event Type  Injury  

Event Description

Mild expected side effect.

Manufacturer Narrative

As detailed above.

• Brand Name: PROSENSE CRYOABLATION SYSTEM
• Type of Device: 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: 18462580
• MDR Text Key: 332253870
• Report Number: 3008797959-2024-00002
• 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: Study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FAS3100000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization