IceRod® 1.5 PLUS 90° Cryoablation Needle FPRPR3508Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 07290104830563), received between Jun 30, 2017 and Sep 29, 2026 — classified as 3 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (12 reports).

1 FDA recall record name this device's identifier.

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 18, 2026.

Recalls naming this device

1. Nov 18, 2020Class IICompleted

   Complaint trend regarding needle shaft gas leaks.

   Z-0666-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Thermal Decomposition of Device

  It was reported that frost occurred on all parts of the needle.An Icerod Plus 90 Degree Needle was selected for a rectal cancer cryoablation procedure. During the procedure, it was observed that frost occurred on all parts of the needle and the freezing range of the cryoablation needle exceeded the intended range. A mild trace of skin hypothermia was reported, and the skin was protected with a warm water bag. The needle was exchanged and the procedure was completed. There were no patient consequences as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938700 ↗
• MalfunctionSep 1, 2026Thermal Decomposition of Device

  It was reported that there was frost on the needle shaft.An Icerod Plus 90 Degree Needle was selected for use in a cryoablation procedure. During the procedure, it was observed that the entire needle shaft was covered in frost. The procedure was immediately halted; the needle was warmed and removed. The patient suffered mild frostbite on the skin, which was treated with warm water compresses. This was a first-degree burn. The cryoablation needle was replaced with another of the same to complete the procedure. It was noted that patient treatment was delayed as a result of this event.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 50553607 ↗
• MalfunctionAug 24, 2026Thermal Decomposition of Device

  It was reported that shaft frost occurred.An Icerod Plus 90 Degree Needle was selected for use. During device preparation, the needle frosted up the shaft. The needle was exchanged and the procedure was completed. There were no patient consequences as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50419161 ↗
• MalfunctionAug 6, 2026Thermal Decomposition of Device

  It was reported that frost occurred on the shaft. An Icepearl 2.1 CX 90 Degree Needle was selected for a lung ablation. During preparation frost was noted on the needle shaft. The procedure was not completed due to an unrelated reason. There were no patient consequences as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50157207 ↗
• MalfunctionDec 9, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THE PROCEDURE A LEAK OCCURRED. AN ICEROD PLUS 90 DEGREE NEEDLE WAS SELECTED FOR A CRYOABLATION PROCEDURE TO TREAT A MALIGNANT TUMOR LOCATED IN THE LIVER. DURING THE TESTING PHASE PRIOR TO THE PROCEDURE, A LEAK WAS OBSERVED FROM THE ICEROD PLUS 90 DEGREE NEEDLE. THE ICEROD PLUS 90 DEGREE NEEDLE WAS NOT USED, AND A DIFFERENT DEVICE OF THE SAME MODEL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23755071 ↗
• MalfunctionOct 13, 2023Insufficient Cooling; Defective Device; Insufficient Cooling; Defective Device

  IT WAS REPORTED THAT AN ADDITIONAL SURGERY WAS REQUIRED AFTER INSUFFICIENT ICE WAS OBSERVED. THREE ICEROD PLUS 90 DEGREE NEEDLES WERE USED IN A LIVER CRYOABLATION PROCEDURE. THE SPACING BETWEEN THE NEEDLES WAS 1.5 CM. DURING THE PROCEDURE, HOWEVER, IT WAS NOTICED THAT THERE WAS A DELAY IN THE ICE FORMATION, AND THE ICEBALL WAS SMALLER THAN WAS EXPECTED. DESPITE CHANGING THE NEEDLES TO OTHER CHANNELS AND OTHER TROUBLESHOOTING MEASURES, THE NEEDLES STILL DID NOT FREEZE. DUE TO THE INSUFFICIENT ICE COVERAGE, THE PROCEDURE WAS NOT ABLE TO BE COMPLETED, AND ANOTHER WAS SCHEDULED FOR A LATER DATE. THE REPEAT SURGERY RESOLVED THE INCIDENT, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17931786 ↗
• MalfunctionOct 13, 2023Insufficient Cooling; Defective Device; Insufficient Cooling; Defective Device

  IT WAS REPORTED THAT AN ADDITIONAL SURGERY WAS REQUIRED AFTER INSUFFICIENT ICE WAS OBSERVED. THREE ICEROD PLUS 90 DEGREE NEEDLES WERE USED IN A LIVER CRYOABLATION PROCEDURE. THE SPACING BETWEEN THE NEEDLES WAS 1.5 CM. DURING THE PROCEDURE, HOWEVER, IT WAS NOTICED THAT THERE WAS A DELAY IN THE ICE FORMATION, AND THE ICEBALL WAS SMALLER THAN WAS EXPECTED. DESPITE CHANGING THE NEEDLES TO OTHER CHANNELS AND OTHER TROUBLESHOOTING MEASURES, THE NEEDLES STILL DID NOT FREEZE. DUE TO THE INSUFFICIENT ICE COVERAGE, THE PROCEDURE WAS NOT ABLE TO BE COMPLETED, AND ANOTHER WAS SCHEDULED FOR A LATER DATE. THE REPEAT SURGERY RESOLVED THE INCIDENT, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17931781 ↗
• MalfunctionOct 13, 2023Insufficient Cooling; Defective Device; Insufficient Cooling; Defective Device

  IT WAS REPORTED THAT AN ADDITIONAL SURGERY WAS REQUIRED AFTER INSUFFICIENT ICE WAS OBSERVED. THREE ICEROD PLUS 90 DEGREE NEEDLES WERE USED IN A LIVER CRYOABLATION PROCEDURE. THE SPACING BETWEEN THE NEEDLES WAS 1.5 CM. DURING THE PROCEDURE, HOWEVER, IT WAS NOTICED THAT THERE WAS A DELAY IN THE ICE FORMATION, AND THE ICEBALL WAS SMALLER THAN WAS EXPECTED. DESPITE CHANGING THE NEEDLES TO OTHER CHANNELS AND OTHER TROUBLESHOOTING MEASURES, THE NEEDLES STILL DID NOT FREEZE. DUE TO THE INSUFFICIENT ICE COVERAGE, THE PROCEDURE WAS NOT ABLE TO BE COMPLETED, AND ANOTHER WAS SCHEDULED FOR A LATER DATE. THE REPEAT SURGERY RESOLVED THE INCIDENT, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17931779 ↗
• MalfunctionDec 20, 2022Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT FROST WAS OBSERVED ON THE NEEDLE SHAFT. THIS ICEROD PLUS 90 DEGREE NEEDLE WAS SELECTED FOR A PERCUTANEOUS CRYOABLATION PROCEDURE FOR RESIDUAL TUMOR AFTER TACE FOR LIVER CANCER. DURING THE TESTING PHASE, THE WHOLE NEEDLE WAS FOUND TO BE COVERED WITH FROST. THE NEEDLE WAS NOT USED FOR THE PROCEDURE; NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16016896 ↗
• InjuryDec 3, 2021Material Separation; Material Separation

  IT WAS REPORTED MATERIAL SEPARATION OCCURRED. A RENAL CRYOABLATION PROCEDURE WAS PERFORMED IN THE KIDNEY, USING TWO ICEROD PLUS CRYOABLATION NEEDLES. THE PROCEDURE ITSELF WAS COMPLETED WITHOUT ANY PROBLEM, HOWEVER, A WHITE SPOT WAS OBSERVED WHEN THE COMPUTED TOMOGRAPHY (CT) SCAN WAS TAKEN AFTER THE REMOVAL OF THE NEEDLE, INDICATING THAT SOMETHING MIGHT HAVE BEEN LEFT INSIDE THE BODY. A CT SCAN WAS PERFORMED AGAIN AFTER A FEW HOURS AND SHOWED NOTHING UNUSUAL. THE NEEDLES WERE VISIBLY REVIEWED AND NO DEFECTS ON THE NEEDLES WERE APPARENT. NO ADDITIONAL INTERVENTION WAS PERFORMED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body Embolism

  MAUDE report 12926283 ↗
• InjuryDec 3, 2021Material Separation; Material Separation

  IT WAS REPORTED MATERIAL SEPARATION OCCURRED. A RENAL CRYOABLATION PROCEDURE WAS PERFORMED IN THE KIDNEY, USING TWO ICEROD PLUS CRYOABLATION NEEDLES. THE PROCEDURE ITSELF WAS COMPLETED WITHOUT ANY PROBLEM, HOWEVER, A WHITE SPOT WAS OBSERVED WHEN THE COMPUTED TOMOGRAPHY (CT) SCAN WAS TAKEN AFTER THE REMOVAL OF THE NEEDLE, INDICATING THAT SOMETHING MIGHT HAVE BEEN LEFT INSIDE THE BODY. A CT SCAN WAS PERFORMED AGAIN AFTER A FEW HOURS AND SHOWED NOTHING UNUSUAL. THE NEEDLES WERE VISIBLY REVIEWED AND NO DEFECTS ON THE NEEDLES WERE APPARENT. NO ADDITIONAL INTERVENTION WAS PERFORMED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body Embolism

  MAUDE report 12926137 ↗
• MalfunctionAug 26, 2020Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT A CRYOABLATION NEEDLE FORMED FROST DURING THE SECOND FREEZE CYCLE OF THE CRYOABLATION PROCEDURE. FROSTBITE WAS OBSERVED NEAR THE CRYOABLATION NEEDLE ENTRY SITE OF THE PATIENT'S SKIN. THE PATIENT WAS TREATED FOR FROSTBITE, BUT THE INJURY WAS NOT SERIOUS IN NATURE AND DID NOT REQUIRE INTERVENTION TO PREVENT SERIOUS INJURY OR IMPAIRMENT. FROST FORMATION WAS NOT OBSERVED DURING TESTING OF THE CRYOABLATION NEEDLE. THE USER ATTEMPTED TO IRRIGATE THE SKIN AROUND THE INSERTION SITE WITH SALINE, BUT THE IRRIGATION WAS AS NOT AS EFFECTIVE AS OBSERVED IN PRIOR EXPERIENCE WITH PREVIOUS MODELS OF THE CRYOABLATION NEEDLE. THE NEEDLE WITH THE REPORTED FROST FORMATION WAS NOT USED IN THE THIRD FREEZE CYCLE OF THE CRYOABLATION PROCEDURE. THE CASE WAS COMPLETED WITH NO FURTHER REPORTED INJURY TO THE PATIENT.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 10454168 ↗
• MalfunctionDec 6, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THIS IS A FOLLOW UP #1 TO REPORT INVESTIGATION FINDINGS OF THE RETURNED NEEDLE. AS REPORTED IN THE INITIAL: IT WAS REPORTED THAT 4 ICEROD NEEDLES WERE USED FOR A RENAL CRYOABLATION PROCEDURE. TOWARDS THE END OF THE FIRST 8 MINUTE FREEZE CYCLE, IT WAS NOTICED THAT THE SHAFT OF ONE OF THE NEEDLES HAD FROZEN. THEY CONTINUED THE FREEZE UNTIL TEN MINUTES. THE NEEDLE WAS KEPT IN SITU AND USED FOR THE SECOND FREEZE CYCLE, BUT THEY APPLIED WARM SALINE TO THE PATIENT'S SKIN AND NEEDLE. IT WAS ALSO REPORTED THAT THE ICEBALL FORMED OK, BUT CRACKED. THIS WAS NOT THOUGHT TO BE DUE TO THE NEEDLE. IT IS UNKNOWN WHICH LOT NUMBER APPLIES TO THE FAULTY NEEDLE. THE NEEDLE WILL BE RETURNED FOR INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9427944 ↗
• MalfunctionMay 15, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DURING THE FIRST FREEZE CYCLE THE DOCTOR NOTICED THE SHAFT OF ONE OF THE ICEROD NEEDLE STARTED TO COLLECT FROST. THE PATIENT'S SKIN WAS PROTECTED. THE PROCEDURE WAS COMPLETED AS EXPECTED WITH NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8613025 ↗
• MalfunctionJun 29, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  PRIOR TO A CRYOABLATION PROCEDURE,FOUR ICEROD PLUS 90° CRYOABLATION NEEDLES AND SYSTEM TESTED FINE WITH NO ISSUES TO REPORT. DURING THE FIRST FREEZE CYCLE THE DOCTOR NOTICED THE SHAFT OF ONE OF THE NEEDLE STARTED TO COLLECT FROST. THE PATIENT'S SKIN WAS PROTECTED TO PREVENT ANY INJURY. THE PROCEDURE WAS COMPLETED AS EXPECTED WITH NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7653509 ↗
• MalfunctionMay 29, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  PRIOR TO A CRYOABLATION PROCEDURE, TWO ICEROD PLUS CRYOABLATION NEEDLES AND SYSTEM TESTED FINE WITH NO ISSUES TO REPORT. DURING THE FIRST FREEZE CYCLE THE TECHNICIAN NOTICED THE SHAFT OF ONE OF THE NEEDLE STARTED TO COLLECT FROST. THE PATIENT'S SKIN WAS COVERED WITH SALINE TO PREVENT ANY INJURY. THE PROCEDURE WAS COMPLETED AS EXPECTED WITH NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7551317 ↗
• MalfunctionNov 8, 2017Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem

  THE SUBJECT WAS ENROLLED IN THE MOTION STUDY IN (B)(6) 2017 AND UNDERWENT CRYOABLATION PROCEDURE ON 27JUL17 FOR A 12.1 X 4.3 X 4.8 CM METASTATIC LESION IN THE RIGHT TIBIA IN WHICH 7 NEEDLES WERE USED. FOLLOWING CRYOABLATION, IT WAS NOTED THAT THE ABLATION ZONE ENCROACHED UPON THE ANTEROMEDIAL SKIN OF THE RIGHT LEG DESPITE ATTEMPTS TO PROTECT THE SKIN WITH WARM SALINE. WARM SALINE BAGS WERE PLACED ON THE SKIN DURING THE PROCEDURE AND LEFT IN PLACE FOR 30 MINUTES AFTER THE CRYO PROCEDURE ENDED. THE OPERATIVE NOTE ALSO INDICATED THE PATIENT WOULD BE REFERRED TO WOUND CARE FOR EVALUATION OF POTENTIAL INJURY TO SKIN. AS A RESULT THAT SHE MAY HAVE SOME SKIN BLISTERING CAUSING HER SIGNIFICANT AMOUNT OF PAIN, AND ALSO CAUSING SOME TACHYCARDIA RELATED TO THE PAIN THE SUBJECT WAS ADMITTED FOR OVERNIGHT OBSERVATION AND PAIN CONTROL. THE WOUND WAS TREATED WITH VISCOPASTE AND ON (B)(6) 2017 THE PATIENT WAS DISCHARGED UNDER CARE OF HOME HEALTH SERVICE. SINCE THE CRYOABLATION PROCEDURE, THE PATIENT HAS BEEN FOLLOWED BY A WOUND CARE CLINIC FOR ROUTINE WOUND CARE. NOTES FROM THIS CLINIC INDICATE THE PATIENT SUFFERED A SECOND DEGREE BURN, MEASURING 7.9 (L) X 8.4 (W) X 0.1 (D) CM. THE PATIENT WAS REF

  Patient problems: Burn, Thermal; Skin Irritation

  MAUDE report 7011050 ↗
• MalfunctionNov 1, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  PRIOR TO A RECTUS ABDOMINUS DESMOID TUMORCRYOABLATION PROCEDURE, FOUR ICEROD PLUS 90° NEEDLES AND SYSTEM TESTED FINE WITH NO ISSUES TO REPORT. THE PHYSICIAN WAS FOCUSED ON HYDRO-DISSECTION OF THE BOWEL AND OBSERVING THE INTRAPROCEDURAL ICEBALL GROWTH AND DID NOT REALIZE THE SHAFTS OF TWO OF THE NEEDLES STARTED TO COLLECT FROST. WHEN HE NOTICED THE FROSTING, THE SKIN AROUND THE NEEDLE INSERTION SITES WAS PURPLE AND HARD, PRESENTING WITH A TYPICAL APPEARANCE OF FREEZING AND LACK OF PERFUSION. HE ATTEMPTED TO INJECT WARM SALINE SUBCUTANEOUSLY, BUT THE SKIN WAS TOO HARD. WARM SALINE WAS THEREFORE APPLIED TO THE SKIN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND DOES NOT PLAN ON ADDITIONAL PROCEDURES. NO INJURY WAS OBSERVED POST-PROCEDURALLY. THE PATIENT RETURNED FOR A 10-DAY POSTOP APPOINTMENT AND THE PHYSICIAN NOTED THAT THE WOUND TO BE APPROXIMATELY 1 CM IN LENGTH. DURING THE 10-DAY POST-PROCEDURE PERIOD, NO WOUND CARE MEASURES WERE TAKEN. PATIENT HAS RECOVERED WITH NO SEQUELAE.

  Patient problems: Burn, Thermal

  MAUDE report 6994317 ↗
• MalfunctionNov 1, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  PRIOR TO A RECTUS ABDOMINUS DESMOID TUMORCRYOABLATION PROCEDURE, FOUR ICEROD PLUS 90° NEEDLES AND SYSTEM TESTED FINE WITH NO ISSUES TO REPORT. THE PHYSICIAN WAS FOCUSED ON HYDRO-DISSECTION OF THE BOWEL AND OBSERVING THE INTRAPROCEDURAL ICEBALL GROWTH AND DID NOT REALIZE THE SHAFTS OF TWO OF THE NEEDLES STARTED TO COLLECT FROST. WHEN HE NOTICED THE FROSTING, THE SKIN AROUND THE NEEDLE INSERTION SITES WAS PURPLE AND HARD, PRESENTING WITH A TYPICAL APPEARANCE OF FREEZING AND LACK OF PERFUSION. HE ATTEMPTED TO INJECT WARM SALINE SUBCUTANEOUSLY, BUT THE SKIN WAS TOO HARD. WARM SALINE WAS THEREFORE APPLIED TO THE SKIN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND DOES NOT PLAN ON ADDITIONAL PROCEDURES. NO INJURY WAS OBSERVED POST-PROCEDURALLY. THE PATIENT RETURNED FOR A 10-DAY POSTOP APPOINTMENT AND THE PHYSICIAN NOTED THAT THE WOUND TO BE APPROXIMATELY 1 CM IN LENGTH. DURING THE 10-DAY POST-PROCEDURE PERIOD, NO WOUND CARE MEASURES WERE TAKEN. PATIENT HAS RECOVERED WITH NO SEQUELAE.

  Patient problems: Burn, Thermal

  MAUDE report 6994303 ↗
• MalfunctionSep 27, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED THAT THE DOCTOR NOTICED THE SHAFTS OF 2 OF THE ICEROD PLUS 90° NEEDLES STARTED TO COLLECT FROST. THE PATIENT'S SKIN WAS PROTECTED TO PREVENT ANY INJURY. THE PROCEDURE WAS COMPLETED AS EXPECTED WITH NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6899322 ↗
• MalfunctionSep 27, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED THAT THE DOCTOR NOTICED THE SHAFTS OF 2 OF THE ICEROD PLUS 90° NEEDLES STARTED TO COLLECT FROST. THE PATIENT'S SKIN WAS PROTECTED TO PREVENT ANY INJURY. THE PROCEDURE WAS COMPLETED AS EXPECTED WITH NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6899297 ↗
• MalfunctionSep 26, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  PRIOR TO A CRYOABLATION PROCEDURE, ICEROD PLUS 90° NEEDLES AND SYSTEM TESTED FINE WITH NO ISSUES TO REPORT. DURING THE FIRST FREEZE CYCLE THE DOCTOR NOTICED THE SHAFT OF ONE OF THE NEEDLES STARTED TO COLLECT FROST. THE NEEDLE WAS IMMEDIATELY REMOVED AND REPLACED WITH ANOTHER NEEDLE. THE PROCEDURE WAS COMPLETED AS EXPECTED WITH NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6895470 ↗
• MalfunctionSep 7, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  PRIOR TO A CRYOABLATION PROCEDURE, ICEROD PLUS 90° NEEDLES AND SYSTEM TESTED FINE WITH NO ISSUES TO REPORT. DURING THE FIRST FREEZE CYCLE THE DOCTOR NOTICED THE SHAFTS OF ONE OF THE NEEDLES STARTED TO COLLECT FROST. THE PATIENT'S SKIN WAS COVERED WITH SALINE TO PREVENT ANY INJURY. THE PROCEDURE WAS COMPLETED AS EXPECTED WITH NO INJURY TO THE PATIENT. THE USER WAS EXPERIENCED WITH GALIL CRYOABLATION AND THE ICEBALL SIZE WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6848814 ↗
• MalfunctionSep 6, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  PRIOR TO A RENAL CRYOABLATION PROCEDURE, TWO ICE-ROD PLUS 90° NEEDLES AND SYSTEM TESTED FINE WITH NO ISSUES TO REPORT. TWO AND HALF MINUTES INTO THE FIRST FREEZE CYCLE THE DOCTOR NOTICED THE SHAFTS OF ONE OF THE NEEDLES STARTED TO COLLECT FROST. THE PATIENT'S SKIN WAS COVERED WITH SALINE TO PREVENT ANY INJURY. THE PROCEDURE WAS COMPLETED AS EXPECTED WITH NO INJURY TO THE PATIENT. THE USER WAS EXPERIENCED WITH GALIL CRYOABLATION. THERE WERE NO ISSUES REPORTED WITH THE ABLATION ZONE OR THE ICEBALL SIZE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6844466 ↗
• MalfunctionAug 21, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  PRIOR TO A SHOULDER CASE CRYOABLATION PROCEDURE, TWO ICEROD PLUS 90°NEEDLES AND SYSTEM TESTED FINE WITH NO ISSUES TO REPORT. ABOUT A MINUTE AND HALF INTO THE FIRST FREEZE CYCLE THE DOCTOR NOTICED THE SHAFTS OF ONE OF THE NEEDLES STARTED TO COLLECT FROST. THE PATIENT'S SKIN WAS COVERED WITH SALINE AND GAUZE TO PREVENT ANY INJURY. THE PROCEDURE WAS COMPLETED AS EXPECTED WITH NO INJURY TO THE PATIENT. THE USER WAS FAMILIAR WITH GALIL CRYOABLATION. THERE WERE NO ISSUES REPORTED WITH THE ABLATION ZONE OR ICEBALL SIZE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6808689 ↗