Visual-ICE® Cryoablation System FPRCH6000Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00867379000006), received between Jun 5, 2017 and Sep 8, 2026 — classified as 2 deaths, 7 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Insufficient Cooling” (33 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Insufficient Cooling

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50679293 ↗
• MalfunctionMay 14, 2026Insufficient Cooling; Temperature Problem

  IT WAS REPORTED THAT SYSTEM INSUFFICIENT ICE OCCURRED. THIS VISUAL-ICE CRYOABLATION SYSTEM WAS SELECTED FOR A CRYOABLATION PROCEDURE. DURING THE PROCEDURE, HOWEVER, IT WAS NOTED THAT THERE WAS A NEGATIVE TEMPERATURE ISSUE, AND THAT THE ICE BALLS WERE TOO SMALL, AS INDICATED BY THE CHARTS. THE PROCEDURE WAS COMPLETED WITH THIS CONSOLE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25175722 ↗
• MalfunctionMar 5, 2026Insufficient Cooling

  IT WAS REPORTED INSUFFICIENT ICE OCCURRED DUE TO THE CONSOLE SYSTEM. DURING PREPARATION PRIOR TO THE PROCEDURE, THE CHANNEL(S) OF THE VISUAL-ICE CRYOABLATION SYSTEM DID NOT FREEZE AS EXPECTED. ADDITIONAL INFORMATION WAS REQUESTED THROUGH THE GOOD FAITH EFFORT (GFE) PROCESS; HOWEVER, NO DETAILS HAVE BEEN RECEIVED. THERE IS NO INDICATION THAT A PATIENT COMPLICATION OR SERIOUS HARM OCCURRED DUE TO THIS EVENT AS THE MALFUNCTION OCCURRED PRIOR TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24525053 ↗
• MalfunctionDec 3, 2025Insufficient Cooling; Temperature Problem; Insufficient Cooling; Temperature Problem

  IT WAS REPORTED INSUFFICIENT ICE OCCURRED DUE TO THE CONSOLE SYSTEM. A VISUAL-ICE CRYOABLATION SYSTEM WAS CHOSEN FOR A PROCEDURE TO TREAT A PATIENT. DURING PREPARATION PRIOR TO THE PROCEDURE, THE PHYSICIAN FOUND THAT THE REFRIGERATION WAS ABNORMAL AND INSUFFICIENT ICE OCCURRED. A DIFFERENT SYSTEM OF A DIFFERENT MODEL WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY AFTER THE PROCEDURE, A BLOCKAGE AT AIR/GAS CONNECTION OF THE VISUAL-ICE CRYOABLATION SYSTEM WAS NOTED. THROUGH TROUBLESHOOTING STEPS, THE VISUAL-ICE CRYOABLATION SYSTEM GAS CONNECTION WAS CLEARED, AND THE VISUAL-ICE CRYOABLATION SYSTEM IS FULLY FUNCTIONAL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23705617 ↗
• MalfunctionDec 2, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT PROCEDURE CANCELLATION OCCURRED. A VISUAL-ICE CRYOABLATION SYSTEM WAS SELECTED FOR A CRYOABLATION PROCEDURE TO TREAT RENAL CELL CARCINOMA. HOWEVER, IT WAS NOTICED THAT THE CONSOLE KEPT LOSING POWER AND REBOOTING ANY TIME IT WAS MOVED. THE CONNECTIONS WERE CHECKED, AND IT IS POSSIBLE THERE WAS A LOOSE CONNECTION OR FAULTY CABLE. REGARDLESS OF WHETHER THE MACHINE IS PLUGGED IN TO THE WALL OR AN EXTENSION LEAD, THE CONSOLE LOST POWER. THE PROCEDURE WAS CANCELLED AFTER THE PATIENT WAS ANESTHETIZED, LEAVING THE RENAL CELL CARCINOMA UNTREATED. A BIOPSY WAS PERFORMED AS IT WAS ALREADY PLANNED AT THE SAME TIME AS THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693403 ↗
• MalfunctionNov 12, 2025Insufficient Cooling; Application Program Problem; Insufficient Cooling; Application Program Problem

  IT WAS REPORTED THAT SYSTEM INSUFFICIENT ICE OCCURRED. A VISUAL-ICE CRYOABLATION SYSTEM WAS SELECTED FOR A CRYOABLATION PROCEDURE. DURING THE PROCEDURE, IT WAS FOUND THAT THE DEVICE WAS NOT COOLING PROPERLY AND THE MANUAL DEFLATION VALVE WAS ALSO MALFUNCTIONING. THE SYSTEM WAS ABLE TO BE USED TO COMPLETE THE PROCEDURE WITH NO PATIENT COMPLICATIONS. THE SYSTEM IS STILL CURRENTLY IN OPERATION, AWAITING REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536437 ↗
• MalfunctionJul 30, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THE SYSTEM'S TOUCHSCREEN MALFUNCTIONED AND THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. DURING A CRYOABLATION PROCEDURE, THE TOUCHSCREEN OF THE VISUAL ICE ZERO COST SYSTEM MALFUNCTIONED. SEDATION AT THE TIME OF THE MALFUNCTION IS UNKNOWN. THE PROCEDURE WAS CANCELLED/RESCHEDULE DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22664789 ↗
• MalfunctionMay 20, 2025Insufficient Cooling; Insufficient Heating; Gas/Air Leak; Insufficient Cooling; Insufficient Heating; Gas/Air Leak

  IT WAS REPORTED INSUFFICIENT ICE OCCURRED DUE TO THE SYSTEM. THE VISUAL-ICE CRYOABLATION SYSTEM WAS UNABLE TO FREEZE AS EXPECTED DURING THE FIRST CYCLE AND ACTIVE HEATING COULD NOT BE USED. INSUFFICIENT GAS PRESSURE WAS NOTED AS WELL. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22056556 ↗
• MalfunctionMay 6, 2025Insufficient Cooling; Display or Visual Feedback Problem; Mechanical Problem; Insufficient Cooling; Display or Visual Feedback Problem; Mechanical Problem

  IT WAS REPORTED INSUFFICIENT ICE OCCURRED. A VISUAL-ICE CRYOABLATION SYSTEM WAS CHOSEN TO COMPLETE A CRYOABLATION PROCEDURE. A CHANNEL ISSUE TRANSPIRED ON THE ALL THE TOP CHANNELS RESULTING IN INSUFFICIENT ICE BEING FORMED BY THE SYSTEM. THE GAS READING ON THE MACHINE WAS NOT THE SAME AS THE CYLINDER EVEN WHEN THE CYLINDER WAS FULL. THE ORIGINAL SYSTEM WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971212 ↗
• MalfunctionApr 29, 2025Insufficient Cooling; Temperature Problem; Insufficient Cooling; Temperature Problem

  IT WAS REPORTED THAT INSUFFICIENT ICE OCCURRED. A VISUAL-ICE CRYOABLATION SYSTEM WAS SELECTED FOR A CRYOABLATION PROCEDURE. DURING THE FREEZING PHASE, HOWEVER, SEVERAL NEEDLES THAWED, AND THE THERMOSENSORS DETECTED A RISE IN TEMPERATURE DESPITE HAVING SUFFICIENT ARGON. THE CASE WAS ABLE TO BE COMPLETED, THOUGH IT IS BELIEVED THAT THE ICEBALL WAS AFFECTED. TRANSRECTAL ULTRASOUND WAS USED TO CHECK IT VISUALLY, BUT WHEN A NEEDLE WAS ACTIVE, THE ICE COULD NOT BE SEEN. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21929045 ↗
• MalfunctionMar 19, 2025Insufficient Cooling; Gas/Air Leak; Insufficient Cooling; Gas/Air Leak

  IT WAS REPORTED THAT INSUFFICIENT ICE OCCURRED. A VISUAL ICE CRYOABLATION SYSTEM WAS SELECTED FOR A CRYOABLATION PROCEDURE TO TREAT A KIDNEY TUMOR. AFTER TESTING, THE NEEDLES WERE CONNECTED TO CHANNELS 1 AND 3. WHEN STICK MODE WAS PERFORMED, THERE WAS A SOUND OF GAS LEAKING FROM INSIDE THE CONSOLE. THE CONSOLE WAS RESTARTED, BUT THE LEAKING SOUND CONTINUED. AFTER CHANGING THE NEEDLES TO CHANNELS 5 AND 7, THE GAS LEAK BECAME SMALLER. HOWEVER, THE ICEBALL FORMATION WAS SMALLER THAN USUAL. A THIRD NEEDLE WAS ADDED, AND THE CRYOTHERAPY WAS CONTINUED. IT IS SUSPECTED THAT THE AUTO VENT SOLENOID VALVES IN THE CONSOLE WERE NOT COMPLETELY CLOSED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21647514 ↗
• InjuryDec 13, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT ICEBALL GREW LARGE ENOUGH TO SURROUND THE NERVE. THIS VISUAL-ICE CRYOABLATION SYSTEM WAS USED WITH 15 NEEDLES TO TREAT A DESMOID TUMOR. DURING THE SECOND FREEZE CYCLE, THE ICEBALL WAS GETTING CLOSE TO A NERVE. THE SIX PROBES ON THAT MARGIN CLOSEST TO THE NERVE WERE ALL SET TO ACTIVE THAW USING HELIUM. AFTER BEING SET TO ACTIVE THAW, CONSTANT MRI IMAGING OBSERVED THAT THE ICEBALL GREW TOWARD THE NERVE FOR TWO ADDITIONAL MINUTES AFTER BEING PLACED INTO ACTIVE THAW. THE ICEBALL ULTIMATELY ENCOMPASSED THE NERVE CAUSING THE PATIENT DISCOMFORT/PAIN AND FOOT DROP SYNDROME. FURTHER DETAILS WERE REQUESTED TO OBTAIN ANY ADDITIONAL INTERVENTION PROVIDED; HOWEVER, NO FURTHER DETAILS WERE AVAILABLE.

  Patient problems: Movement Disorder; Nerve Damage; Pain

  MAUDE report 20923943 ↗
• MalfunctionNov 18, 2024Insufficient Cooling; Insufficient Cooling

  IT WAS REPORTED INSUFFICIENT ICE OCCURRED. PRIOR TO THE PROCEDURE DURING TESTING, THE VISUAL-ICE CRYOABLATION SYSTEM WAS UNABLE TO FREEZE AS EXPECTED. THE STAFF REALIZED THAT THE GAS OUTPUT WAS AT 20 PERCENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE ORIGINAL SYSTEM AND DIFFERENT NEEDLES. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20708819 ↗
• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE 53RD ANNUAL MEETING OF THE JAPANESE SOCIETY OF INTERVENTIONAL RADIOLOGY, THE SESSION CHAIR REVIEWED CASE REPORTS OF PULMONARY EMBOLISM WITH THE USE OF CRYOABLATION. CASE REVIEW OF RETROSPECTIVE STUDY FROM (B)(6) 2022 TO (B)(6) 2023, 71 PATIENTS (50 MALES, 21 FEMALES, AGED 23-88, AVERAGE 66 YEARS) WITH 77 TUMORS WHO UNDERWENT CRYOABLATION FOR RENAL CANCER AT OUR HOSPITAL WERE INCLUDED IN THIS STUDY. PULMONARY THROMBOEMBOLISM WAS OBSERVED ON CONTRAST-ENHANCED CT IN 10.4% (8/77) OF THE CASES 1-3 DAYS AFTER CRYOABLATION THERAPY, ALL OF WHICH WERE ASYMPTOMATIC. SIX CASES WERE TREATED WITH ORAL EDOXABAN, ONE CASE WITH ORAL ASPIRIN, AND ONE CASE WAS MONITORED WITHOUT MEDICATION. FOLLOW-UP CONTRAST-ENHANCED CT AT ONE MONTH SHOWED THAT THE THROMBUS HAD DISAPPEARED IN SEVEN CASES, BUT THE CASE TREATED WITH ASPIRIN COULD NOT BE EVALUATED AS THE CHEST WAS OUTSIDE THE IMAGING RANGE. MAY 25, 2024 (SATURDAY) 13:20 - 14:15 VENUE 6 GENERAL PRESENTATION OF RENAL CRYOTHERAPY CHAIR: HARUYUKI TAKAGI, DEPARTMENT OF RADIOLOGY, HYOGO MEDICAL UNIVERSITY, TAKAO HIRAKI, RADIOLOGY, OKAYAMA UNIVERSITY GRADUATE SCHOOL OF MEDICINE, DENTISTRY AND PHARMACEUTICAL SCIENCES. ABSTRACT P

  Patient problems: Pulmonary Embolism

  MAUDE report 19578074 ↗
• MalfunctionJan 4, 2024Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A VISUAL-ICE CRYOABLATION SYSTEM WAS SELECTED FOR A CRYOABLATION PROCEDURE. DURING THE PROCEDURE, HOWEVER, THE CONSOLE HAD SHUT DOWN AND WOULD NOT RESTART. AS A RESULT, THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18446315 ↗
• MalfunctionJan 4, 2024Insufficient Cooling; Insufficient Cooling

  IT WAS REPORTED THAT THERE WAS INSUFFICIENT ICE FORMATION. A CRYO CONSOLE WAS SELECTED FOR USE FOR A CRYOABLATION PROCEDURE. DURING TREATMENT, THERE WAS INADEQUATE TREATMENT DUE TO INSUFFICIENT ICE FORMATION DURING THE SECOND FREEZE PERIODS. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18445242 ↗
• MalfunctionDec 12, 2023Insufficient Cooling; Temperature Problem; Insufficient Cooling; Temperature Problem

  IT WAS REPORTED THAT INSUFFICIENT ICE OCCURRED. A VISUAL-ICE CRYOABLATION SYSTEM WAS SELECTED FOR A RENAL CRYOABLATION PROCEDURE. IT WAS NOTED THAT THERE WERE NO PROBLEMS WHEN THE NEEDLES WERE TESTED; HOWEVER, DURING THE PROCEDURE, NONE OF THE THREE NEEDLES USED REACHED -120 DEGREES. CONSEQUENTLY, THE ICE BALL IN THE TUMOR WAS UNSATISFACTORY. THE PHYSICIAN WAS NOT SATISFIED WITH THE TREATMENT, AND THE FOLLOW-UP CT SCAN WILL BE PERFORMED IN TWO MONTHS TO DETERMINE THE OUTCOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311601 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED A FRACTURE OF THE FEMUR AT THE LOCATION OF THE TUMOR. THIS VISUAL-ICE CRYOABLATION SYSTEM WAS USED TO TREAT A TUMOR IN THE FEMUR OF A YOUNG PATIENT. POST-PROCEDURE THE PATIENT HAD EXPERIENCED A FRACTURE OF THE FEMUR AT THE LOCATION OF THE TUMOR. THE PATIENT WAS ADMITTED FOR FURTHER CARE; HOWEVER, NO FURTHER DETAILS WERE APPROVED TO BE DISCLOSED BY THE FACILITY DIRECTOR.

  Patient problems: Limb Fracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17869358 ↗
• MalfunctionJun 26, 2023Insufficient Cooling; Temperature Problem; Insufficient Cooling; Temperature Problem

  IT WAS REPORTED THAT THERE WAS INSUFFICIENT ICE CAUSED BY THE CONSOLE. A VISUAL-ICE CRYOABLATION SYSTEM WAS OBSERVED TO ONLY REACH A TEMPERATURE OF 105 DEGREES, REGARDLESS OF WHICH NEEDLE OR WHICH CHANNEL IS USED. A NEEDLE WAS TESTED BY THE BOSTON SCIENTIFIC REPRESENTATIVE AS WELL, AND THE DESIRED ICE BALL DIMENSIONS WERE NOT REACHED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17201501 ↗
• MalfunctionMay 26, 2023Insufficient Cooling; Mechanical Problem; Insufficient Cooling; Mechanical Problem

  IT WAS REPORTED THAT THERE WAS INSUFFICIENT ICE CAUSED BY THE CONSOLE. A VISUAL-ICE CRYOABLATION SYSTEM WAS SELECTED FOR A RENAL CRYOABLATION PROCEDURE TO TREAT A KIDNEY TUMOR. SERVICE WAS PERFORMED ON THE 3RD AND 4TH OF APRIL, 8 DAYS PRIOR TO THE PROCEDURE, AND IT WAS NOTED THAT THE CONSOLE WAS 12 YEARS OLD. DURING THE PROCEDURE, ONE OF THE NEEDLES DIDN'T FREEZE PROPERLY. AN I-THAW ERROR MESSAGE WAS ALSO DISPLAYED. THE CASE WAS COMPLETED BY SWITCHING TO HELIUM. THE TREATMENT WAS SUFFICIENT IN TREATING THE KIDNEY TUMOR, AND NO COMPLICATIONS WERE REPORTED. THE PATIENT HAD FULLY RECOVERED AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17010925 ↗
• MalfunctionMay 26, 2023Insufficient Cooling; Insufficient Cooling

  IT WAS REPORTED THAT THERE WAS INSUFFICIENT ICE CAUSED BY THE CONSOLE. A VISUAL-ICE CRYOABLATION SYSTEM WAS SELECTED FOR A RENAL CRYOABLATION PROCEDURE TO TREAT A KIDNEY TUMOR. SERVICE WAS PERFORMED ON THE (B)(6), 10 DAYS PRIOR TO THE PROCEDURE. DURING THE PROCEDURE, HOWEVER, INSUFFICIENT ICE WAS OBSERVED DURING THE FIRST FREEZE CYCLE. AN ICEFX SYSTEM REPLACED THE VISUAL-ICE SYSTEM FOR THE SECOND FREEZE, AND THE FREEZING TIME WAS EXTENDED FOR 2 MINUTES TO ACHIEVE ADEQUATE ICE COVER. THE TREATMENT WAS SUFFICIENT AFTER THE SECOND FREEZE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE VISUAL-ICE CRYOABLATION SYSTEM WAS REMOVED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17010212 ↗
• MalfunctionJan 27, 2023Mechanical Problem; Output Problem; Mechanical Problem; Output Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELED DUE TO A FAULT IN THE CRYOABLATION SYSTEMS. A VISUAL-ICE CRYOABLATION SYSTEM WAS SELECTED FOR A RENAL CRYOABLATION PROCEDURE. DURING THE PROCEDURE SET-UP, THE NEEDLES WERE INSERTED, AND ONE OF THE CHANNELS DID NOT LOG ANY NEEDLES. THE NEEDLES WERE MOVED TO A NEW CHANNEL, BUT THE SCREEN GREYED OUT AND NO BUTTONS COULD BE PRESSED. THE VISUAL-ICE CRYOABLATION SYSTEM WAS EXCHANGED FOR A SECOND VISUAL-ICE CRYOABLATION SYSTEM, AND THE NEEDLES WERE ALSO EXCHANGED FOR NEW ONES. HOWEVER, THE SAME FAULTS OCCURRED WITH THE NEW CONSOLE AND NEEDLES. THE PROCEDURE WAS RESCHEDULED TO A LATER DATE AS A RESULT. THE PATIENT WAS SEDATED UNDER GENERAL ANESTHESIA AT THE TIME OF THE PROCEDURE CANCELLATION. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16255863 ↗
• MalfunctionJan 27, 2023Mechanical Problem; Output Problem; Mechanical Problem; Output Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELED DUE TO A FAULT IN THE CRYOABLATION SYSTEMS. A VISUAL-ICE CRYOABLATION SYSTEM WAS SELECTED FOR A RENAL CRYOABLATION PROCEDURE. DURING THE PROCEDURE SET-UP, THE NEEDLES WERE INSERTED, AND ONE OF THE CHANNELS DID NOT LOG ANY NEEDLES. THE NEEDLES WERE MOVED TO A NEW CHANNEL, BUT THE SCREEN GREYED OUT AND NO BUTTONS COULD BE PRESSED. THE VISUAL-ICE CRYOABLATION SYSTEM WAS EXCHANGED FOR A SECOND VISUAL-ICE CRYOABLATION SYSTEM, AND THE NEEDLES WERE ALSO EXCHANGED FOR NEW ONES. HOWEVER, THE SAME FAULTS OCCURRED WITH THE NEW CONSOLE AND NEEDLES. THE PROCEDURE WAS RESCHEDULED TO A LATER DATE AS A RESULT. THE PATIENT WAS SEDATED UNDER GENERAL ANESTHESIA AT THE TIME OF THE PROCEDURE CANCELLATION. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16255154 ↗
• MalfunctionDec 19, 2022Insufficient Cooling; Insufficient Cooling

  IT WAS REPORTED THAT A PROCEDURE WAS CANCELED DUE TO NO ICE FORMATION DURING PREPARATION. AN ICEFX CRYOABLATION SYSTEM WAS USED TOGETHER WITH A 5 ICEROD I-THAW PROSTATE KIT FOR A CRYOABLATION PROCEDURE TO TREAT PROSTATE CANCER. DURING TESTING, HOWEVER, THE I-THAW NEEDLES DID NOT PRODUCE ICE. A NEW NEEDLE WAS EXCHANGED ON THE CONSOLE, BUT THE ISSUE WAS NOT RESOLVED. DUE TO THIS, THE PROCEDURE WAS RESCHEDULED TO ANOTHER DATE. THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16009714 ↗
• MalfunctionDec 2, 2022Insufficient Cooling; Temperature Problem; Insufficient Cooling; Temperature Problem

  IT WAS REPORTED THAT THIS CONSOLE DID NOT ABLE TO REACH THE OPTIMUM TEMPERATURE OF -120 DEGREES. THIS VISUAL-ICE CRYOABLATION SYSTEM WAS SELECTED FOR THIS PROCEDURE. DURING THE PROCEDURE, IT WAS NOTICED THAT THE TIP OF THE NEEDLE WAS READING -105 DEGREES INSTEAD OF THE OPTIMAL -120 DEGREES. THE SYSTEM ALSO APPEARED TO BE USING LESS GAS THAN EXPECTED. ADDITIONAL INFORMATION SUGGESTED THAT THE ARGON TANK HAD BEEN CHECKED, AND THIS SAME ISSUE HAD OCCURRED DURING OTHER PROCEDURES WITH THIS CONSOLE REGARDLESS OF THE CHANNEL OR NEEDLES. THE ICEBALL WAS SMALLER THAN EXPECTED, HOWEVER THE PATIENT TREATMENT WAS NOTED AS ADEQUATE TO COVER THE TARGETED AREA AND SUCCESSFUL. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15911679 ↗