Cerene Cryotherapy Device FGS-7000Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00850008595035), received between Jun 1, 2023 and May 13, 2026 — classified as 9 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (6 reports).

2 FDA recall records name this device's identifier, 2 still open.

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. Mar 20, 2025Class IIOpen, Classified

   Due to evaporator gasket not sealing which can cause liquid nitrous oxide to drip/leak from the bottom of the device handle during treatment or after treatment during venting of the device

   Z-1584-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. May 3, 2024Class IIOpen, Classified

   Error code 003 was not listed in certain rows of the Device Instructions for Use Troubleshooting section (i.e., Table 22. Summary of LCD Messages and Error Codes).

   Z-1889-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  PRIOR TO TREATMENT WITH THE CERENE CRYOTHERAPY DEVICE, THE PATIENT RECEIVED A PARACERVICAL BLOCK AND EXPERIENCED RINGING IN HER EARS AND A RACING HEART. AFTER 2-2.5 HOURS OF WAITING AT THE PHYSICIAN'S FACILITY, THE PATIENT AND PHYSICIAN DECIDED TO PROCEED WITH CERENE TREATMENT. THE PROCEDURE WAS COMPLETED SUCCESFULLY. FOLLOWING THE PROCEDURE, THE PATIENT WAS ACCOMPANIED TO THE PARKING LOT BY HER HUSBAND, WHERE SHE LOST CONSCIOUSNESS. THE PATIENT WAS TRANSFERRED TO THE EMERGENCY ROOM AND ACCOMPANIED BY THE PHYSICIAN. THE PATIENT WAS RELEASED THE SAME DAY FROM THE HOSPITAL.

  Patient problems: Loss of consciousness

  MAUDE report 25165730 ↗
• MalfunctionNov 26, 2025Use of Device Problem; Use of Device Problem

  THE PHYSICIAN BEGAN TREATMENT WITH THE CERENE CRYOTHERAPY DEVICE. APPROXIMATELY 90 SECONDS INTO NITROUS OXIDE TREATMENT, THE DEVICE SHOWED ERROR CODE 390, STOPPING TREATMENT. THE PHYSICIAN REMOVED THE DEVICE AND ELECTED TO USE ANOTHER DEVICE. THE PROCEDURE WAS COMPLETED WITH A FULL TREATMENT, AND THE PATIENT WAS DISCHARGED. NO ADVERSE EVENTS WERE REPORTED. EVALUATION OF THE LOG DATA FROM THE RETURNED DEVICE SHOWED THAT THE DEVICE WAS PAUSED ~75 SECONDS INTO NITROUS OXIDE TREATMENT WITH EC390 REPORTED 15 SECONDS LATER WHEN THE DEVICE WAS NOT UN-PAUSED WITHIN THE ALLOWABLE WINDOW. AS THERE WERE NO ISSUES OBSERVED WITH THE DEVICE DURING RE-TESTING, THIS WAS DETERMINED TO BE USER ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23660166 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN RESPONSE TO AN EMAIL FROM A COMPANY REPRESENTATIVE, A PHYSICIAN REPORTED THAT A PATIENT HE HAD TREATED WITH THE CERENE CRYOTHERAPY DEVICE HAD DEVELOPED HEMATOMETRA THAT HAD TO BE EVACUATED AFTER SOME UNKNOWN TIME POST-PROCEDURE. IN ADDITIONAL CORRESPONDENCE WITH COMPANY REPRESENTATIVES WHO WERE PRESENT ON THE DAY OF THE PROCEDURE, IT WAS NOTED THAT THE ENDOMETRIAL CRYOABLATION WITH THE CERENE DEVICE MAY HAVE BEEN PERFORMED CONCOMITANTLY WITH A FIBROID REMOVAL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23408046 ↗
• MalfunctionSep 5, 2025Communication or Transmission Problem; Communication or Transmission Problem

  THE PHYSICIAN ENCOUNTERED A DEVICE MALFUNCTION WHILE USING THE CERENE CRYOTHERAPY DEVICE. THE DEVICE OPERATED NORMALLY UNTIL SHORTLY AFTER ACTIVE ABLATIVE TREATMENT HAD STARTED, AT WHICH TIME THE LCD SCREEN DISPLAYED ERROR CODE 307 (SHEATH ENCODER FAULT, TREATMENT). THE DEVICE WAS REMOVED AND THE PHYSICIAN ELECTED TO USE ANOTHER DEVICE. THE PROCEDURE WAS COMPLETED WITH A FULL TREATMENT, AND THE PATIENT WAS DISCHARGED WITH NO INJURY. ANALYSIS OF THE RETURNED DEVICE SHOWED THAT THE EC 307 WAS TRIGGERED AFTER 11 SECONDS OF NITROUS OXIDE TREATMENT; NO FAULT OR OTHER ISSUES WERE OBSERVED DURING RE-TESTING OF THE SUBJECT DEVICE. THE CONCLUSION OF THE INVESTIGATION IS THAT THE MOST LIKELY ROOT CAUSE FOR THE EC 307 WAS AN UNDETERMINED ISSUE WITH THE SHEATH ENCODER PROCESSOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22982474 ↗
• MalfunctionJul 31, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  DURING AN ENDOMETRIAL ABLATION WITH THE CERENE CRYOTHERAPY DEVICE, THE PHYSICIAN BELIEVED THE DEVICE STARTED TREATMENT WITH THE CAVITY LENGTH SET TO 2.5CM. AS THE PHYSICIAN WAS UNSURE OF THE CAVITY LENGTH SETTING, A COMPANY REPRESENTATIVE WHO WAS PRESENT DIRECTED THE PHYSICIAN TO PAUSE THE DEVICE AFTER 8-10 SECONDS OF CRYOTHERAPY HAD ELAPSED AND BEGIN VENTING THE DEVICE. ERROR CODE 301 WAS SHOWN ON THE DEVICE. THE DEVICE WAS REMOVED AND THE PHYSICIAN ELECTED TO USE ANOTHER DEVICE. THE PROCEDURE WAS COMPLETED WITH A FULL TREATMENT, AND THE PATIENT WAS DISCHARGED WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22680984 ↗
• InjuryJul 10, 2025False Positive Result; False Positive Result

  WHILE ATTEMPTING TO PERFORM AN ENDOMETRIAL CRYOABLATION ON A PATIENT WITH THE CERENE CRYOTHERAPY DEVICE, THE PHYSICIAN HAD DIFFICULTY DILATING THE PATIENT'S CERVIX (WHICH THE PATIENT REPORTED AS BEING VERY PAINFUL) AND INSERTED THE DEVICE INTO THE PATIENT PRIOR TO TURNING THE DEVICE ON. THE PHYSICIAN THEN REMOVED THE DEVICE FROM THE PATIENT AND TURNED IT ON, AT WHICH POINT THE DEVICE REPORTED ERROR CODE 120 (SHEATH RETRACTED WITHOUT VACUUM, PRE-INSERTION). THE PHYSICIAN PROCEEDED TO REATTEMPT THE PROCEDURE WITH ANOTHER DEVICE AND TURNED ON THE DEVICE PRIOR TO INSERTION INTO THE PATIENT, AS PER THE INSTRUCTIONS FOR USE, WHILE USING ULTRASOUND DURING INSERTION TO VIEW THE LOCATION OF THE DEVICE (PROBE) AND CONFIRM PROPER PLACEMENT AT THE FUNDUS. AFTER INITIAL DEVICE LINER DEPLOYMENT AND SAFETY CHECKS, THE DEVICE REPORTED AN ERROR CODE "POSSIBLE PERFORATION." AS PER THE IFU "TREATMENT STATUS & NEXT STEPS," THE PHYSICIAN PROCEEDED TO REATTEMPT THE PROCEDURE FOR A 3RD TIME WITH THE THIRD DEVICE ALSO REPORTING AN ERROR CODE "POSSIBLE PERFORATION." THE PHYSICIAN ELECTED TO STOP ANY FURTHER ATTEMPTS, AND THE PATIENT WAS DISCHARGED WITHOUT TREATMENT. THE PATIENT REPORTED THE DAY AFTER THE A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22475073 ↗
• MalfunctionJun 7, 2025Incorrect Measurement; Incorrect Measurement

  THE PHYSICIAN BEGAN TREATMENT WITH THE CERENE CRYOTHERAPY DEVICE WITHOUT ISSUE. AFTER 67 SECONDS OF TREATMENT, THE DEVICE SHOWED ERROR CODE 379 AND STOPPED TREATMENT. THE PHYSICIAN REMOVED AND VENTED THE DEVICE, AND ELECTED TO OPEN A SECOND DEVICE. THE PROCEDURE WAS COMPLETED WITH A FULL TREATMENT, AND THE PATIENT WAS DISCHARGED WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22163244 ↗
• MalfunctionApr 21, 2025Complete Blockage; Improper or Incorrect Procedure or Method; Complete Blockage; Improper or Incorrect Procedure or Method

  THE PHYSICIAN ENCOUNTERED A DEVICE MALFUNCTION WHILE USING THE CERENE CRYOTHERAPY DEVICE. THE DEVICE OPERATED NORMALLY UNTIL 23 SECONDS AFTER ACTIVE ABLATIVE TREATMENT HAD STARTED, AT WHICH TIME THE LCD SCREEN DISPLAYED ERROR CODE 378. THE DEVICE WAS REMOVED FROM THE PATIENT AND VENTED. THE PROCEDURE WAS TERMINATED AND THE PATIENT WAS DISCHARGED WITH NO ADVERSE EVENTS REPORTED. ANALYSIS OF THE RETURNED DEVICE REVEALED THAT A LARGE SPIKE IN PRESSURE TRIGGERED THE EC378 FAULT. VISUAL INSPECTION RESULTED IN NO OBSERVATIONS OF NOTE. RE-TESTING OF THE DEVICE RESULTED IN COMPLETION OF THE TREATMENT SEQUENCE WITHOUT ISSUE. BASED ON THIS DATA AND A PREVIOUS COMPLAINT RECORD, THE LIKELIEST ROOT CAUSE FOR THIS FAULT IS OCCLUSION OF THE COLLECTION TUBING AT THE INTERFACE WITH THE EXHAUST COLLECTION BAG DUE TO UNINTENTIONAL TWISTING OF THE EXHAUST COLLECTION BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876446 ↗
• MalfunctionMar 7, 2025Leak/Splash; Leak/Splash

  DURING A PROCEDURE WITH THE CERENE CRYOTHERAPY DEVICE, THE PHYSICIAN NOTICED LIQUID NITROUS OXIDE LEAKING FROM THE BOTTOM OF THE DEVICE HANDLE DURING THE ACTIVE TREATMENT PORTION OF THE PROCEDURE. HE PAUSED THE DEVICE, BUT THE DRIPPING CONTINUED. THE PHYSICIAN NOTED THAT THE LIQUID NITROUS OXIDE DID DRIP ONTO HIS LEG, LEAVING A BURN. HE STATED THAT HE DID NOT REQUIRE TREATMENT FOR THIS THERMAL INJURY AND EXPECTED IT TO RESOLVE. THE PHYSICIAN STATED THAT HE STOPPED THE DEVICE NEAR THE END OF THE TREATMENT AS IT CONTINUED TO LEAK AND DID NOT NOTE ANY ERROR CODES. HIS ASSISTANT NOTED THAT THE EXHAUST COLLECTION BAG WAS NOT AS FULL AS THEY SEE WITH A TYPICAL PROCEDURE. THE PATIENT WAS DISCHARGED WITH NO INJURY.

  Patient problems: Cryogenic Burn; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21554202 ↗
• MalfunctionNov 21, 2024Mechanics Altered; Power Problem; Mechanics Altered; Power Problem

  THE CERENE CRYOTHERAPY DEVICE WAS USED FOR ENDOMETRIAL ABLATION. THE DEVICE WAS REMOVED FROM THE PACKAGE, PREPARED, TURNED ON, AND INSERTED INTO THE PATIENT. AT AN UNDISCLOSED TIME, THE DEVICE INDICATED ERROR CODE 305. THE PHYSICIAN ELECTED TO OPEN A SECOND DEVICE. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS TREATED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20751199 ↗
• MalfunctionOct 15, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE CERENE CRYOTHERAPY DEVICE REPORTED ERROR CODE 390 DURING THE DELIVERY OF CRYOABLATION. THE PHYSICAN WAS UNCERTAIN WHETHER SHE HAD RETRACTED THE DEVICE TO THE UTERINE CAVITY LENGTH AND MAY HAVE INADVERTENTLY PRESSED THE BUTTON TOO MANY TIMES, PAUSING THE DEVICE (WHICH ULTIMATELY TIMED OUT). THE PHYSICIAN ELECTED TO OPEN A SECOND DEVICE, THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS SUCCESSFULLY TREATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20453432 ↗
• InjurySep 17, 2024Malposition of Device; Malposition of Device

  A PATIENT WITH A UTERINE SOUND LENGTH OF 8.5 CM AND UTERINE CAVITY LENGTH OF 4.5 CM WAS TREATED WITH THE CERENE CRYOTHERAPY DEVICE. THE DEVICE WAS INSERTED INTO THE PATIENT, AFTER WHICH THE DOCTOR SET THE DEVICE TO THE CAVITY LENGTH AND CONFIRMED PLACEMENT OF THE DEVICE AT THE FUNDUS. AFTER ATTEMPTING TO INFLATE, THE DEVICE DISPLAYED "POSSIBLE PERFORATION." THE DEVICE WAS REMOVED, AND THE PHYSICIAN DECIDED TO USE A SECOND DEVICE WITH THE SAME LOT NUMBER. UPON INSERTION, THE PHYSICIAN NOTED THAT THE DEVICE PASSED FAR ENOUGH THAT THE SHEATH MARKING SHOWING AT THE EXTERNAL OS WAS 12 CM. THE PHYSICIAN REMOVED THE DEVICE AND PERFORMED HYSTEROSCOPY. CAVITY VISUALIZATION WAS NOT ACHIEVED, AS THE PHYSICIAN WAS UNABLE TO MAINTAIN FLUID PRESSURE, INDICATING A PERFORATION. THE PATIENT WAS KEPT FOR OBSERVATION FOR A FEW HOURS POST-PROCEDURE AND SENT HOME WITH ANTIBIOTICS EXPECTANTLY. FOLLOW-UP WITH THE PATIENT AT HOME SEVERAL HOURS LATER INDICATED THAT SHE WAS DOING FINE. THE PATIENT RETURNED TO THE OFFICE FOUR DAYS LATER AND WAS REPORTED TO BE DOING FINE.

  Patient problems: Uterine Perforation

  MAUDE report 20242207 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN PERFORMED A PROCEDURE WITH THE CERENE CRYOTHERAPY DEVICE ON APRIL 5TH. THE PROCEDURE WENT WELL; THERE WERE NO MALFUNCTIONS OR ISSUES NOTED AND IT WAS A NORMAL PROCEDURE. THE PATIENT WAS 46 YEARS OLD AND HAD A MEDICAL HISTORY OF C-SECTION AND STERILIZATION THROUGH AN ESSURE PROCEDURE (HYSTEROSCOPIC PROCEDURE). TWO WEEKS POST-PROCEDURE, THE PATIENT HAD FEVER WITHOUT ABDOMINAL PAIN. HER GENERAL PRACTITIONER SUSPECTED A URINARY TRACT INFECTION AND STARTED ANTIBIOTICS. THREE WEEKS AFTER THE PROCEDURE, SHE DEVELOPED ABDOMINAL PAIN AND WAS REFERRED TO THE LOCAL HOSPITAL. SHE WAS ADMITTED WITH SEPSIS, RECEIVED A CT SCAN (WHICH REVEALED AN INFECTION INSIDE THE UTERUS [ENDOMETRITIS]), AND WAS GIVEN ANTIBIOTICS. ANOTHER CT SCAN WAS PERFORMED BECAUSE SHE HAD A RELAPSE WITH INCREASING INFECTION PARAMETERS; AN ABSCESS OF 16CM BETWEEN THE BLADDER AND THE UTERUS AS WELL AS ABOVE THE UTERUS WAS SEEN. NO UTERINE PERFORATION WAS SEEN. THE PATIENT WAS GIVEN ANTIBIOTICS AND A DRAIN. THE PATIENT PERSISTED WITH HIGH FEVER AND WAS MOVED TO THE (B)(6) HOSPITAL IN (B)(6) ON MAY 12TH WHERE SHE WAS AGAIN GIVEN A CT SCAN AND DRAINED. THROMBOSIS IN THE LEFT OVARIAN VEIN WAS FOUND. SHE WAS GIVEN DI

  Patient problems: Abdominal Pain; Abscess; Fever; Pelvic Inflammatory Disease; Sepsis; Urinary Tract Infection

  MAUDE report 19512893 ↗
• MalfunctionMay 10, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE PHYSICIAN REPORTED AN UNSPECIFIED ERROR AND INDICATED THAT A REPLACEMENT DEVICE WAS USED TO PERFORM A COMPLETE PROCEDURE. THE PATIENT WAS DISCHARGED. BASED ON EVALUATION OF THE RETURNED DEVICE, THE LOG INDICATED THAT THE USER PAUSED AND THEN VENTED THE DEVICE 44 SECONDS INTO NITROUS OXIDE TREATMENT, TRIGGERING ERROR CODE 301. THE DEVICE APPEARED TO BE FUNCTIONING AS INTENDED PRIOR TO THE USER PAUSING AND VENTING THE DEVICE. NO OTHER INFORMATION REGARDING WHY THE USER PAUSED AND VENTED THE DEVICE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19283510 ↗
• MalfunctionMay 10, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE PHYSICIAN INSERTED THE DEVICE, WHICH PASSED ALL SAFETY CHECKS AND BEGAN TREATMENT. ABOUT 50 SECONDS INTO TREATMENT, THE DEVICE STOPPED AND FLASHED ERROR CODE 379. THE PHYSICIAN THEN PROCEEDED WITH A NEW DEVICE AND COMPLETED A FULL TREATMENT ON THE PATIENT. THE PATIENT WAS DISCHARGED. LABELING FOR THE CERENE CRYOTHERAPY DEVICE STATES THAT THE "TREATMENT STATUS AND NEXT STEPS" FOR ERROR CODE 379 IS "UTERUS PARTIALLY TREATED, END PROCEDURE, DO NOT RE-TREAT." BASED ON EVALUATION OF THE RETURNED DEVICE, THE ROOT CAUSE FOR THE MALFUNCTION WAS A LEAK AROUND ONE OF THE PRESSURE LINES DURING NITROUS OXIDE FLOW DUE TO TEARING IN THE SILICONE PRESSURE SLEEVE DURING MANUFACTURING. PROCESS UPDATES HAVE SINCE BEEN IMPLEMENTED TO PREVENT THIS FAILURE MODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19283509 ↗
• MalfunctionMay 10, 2024Decrease in Pressure; Decrease in Pressure

  THE PHYSICIAN INSERTED THE DEVICE, WHICH PASSED ALL SAFETY CHECKS AND BEGAN TREATMENT. ABOUT 18 SECONDS INTO TREATMENT, THE DEVICE STOPPED AND FLASHED ERROR CODE 377. THE PHYSICIAN THEN PROCEEDED WITH A NEW DEVICE. THE PATIENT WAS DISCHARGED. NO ADVERSE EVENTS OR INJURY WERE REPORTED. THE DEVICE WAS NOT RETURNED FOR EVALUATION, SO THE FAILURE MODE COULD NOT BE DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19283507 ↗
• MalfunctionMay 10, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE PROCEDURE WAS CONDUCTED IN THE OFFICE SETTING. A FEW SECONDS AFTER THE ABLATION CYCLE BEGAN, ERROR CODE 379 WAS DISPLAYED ON THE DEVICE AND THE PROCEDURE STOPPED. VENTING WAS INITIATED AND THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT. THE PHYSICIAN THEN PROCEEDED WITH A NEW DEVICE AND COMPLETED A FULL TREATMENT ON THE PATIENT. THE PATIENT WAS DISCHARGED. NO ADVERSE EVENTS OR INJURY WERE REPORTED. BASED ON EVALUATION OF THE RETURNED DEVICE, THE ROOT CAUSE FOR THE MALFUNCTION WAS TEARING IN THE SILICONE PRESSURE SLEEVE DURING MANUFACTURING. PROCESS UPDATES HAVE SINCE BEEN IMPLEMENTED TO HELP PREVENT THIS FAILURE MODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19283503 ↗
• MalfunctionMay 10, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  AFTER THE FIRST DEVICE USED IN THE PROCEDURE MALFUNCTIONED, THE PHYSICIAN OPENED THIS DEVICE. HE INSERTED THE DEVICE, WHICH WENT THROUGH SAFETY CHECKS AND THE TREATMENT BEGAN. AFTER ABOUT 6 SECONDS OF TREATMENT, ERROR CODE 379 WAS SHOWN ON THE DEVICE. THE PHYSICIAN REMOVED THE DEVICE AND NOTED THERE WAS NO INJURY TO THE PATIENT. THE PHYSICIAN THEN OPENED A THIRD DEVICE AND COMPLETED A FULL TREATMENT ON THE PATIENT. THE PATIENT WAS DISCHARGED. NO ADVERSE EVENTS OR INJURY WERE REPORTED. BASED ON EVALUATION OF THE RETURNED DEVICE, THE ROOT CAUSE FOR THE MALFUNCTION WAS TEARING IN THE SILICONE PRESSURE SLEEVE DURING MANUFACTURING. PROCESS UPDATES HAVE SINCE BEEN IMPLEMENTED TO HELP PREVENT THIS FAILURE MODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19283501 ↗
• MalfunctionMay 10, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THIS WAS THE SECOND DEVICE USED BY THE PHYSICIAN. AFTER 6 SECONDS OF CRYO TREATMENT, THE DEVICE FLASHED ERROR CODE 379. THE PHYSICIAN THEN PROCEEDED WITH A THIRD DEVICE AND COMPLETED A FULL TREATMENT ON THE PATIENT. THE PATIENT WAS DISCHARGED. NO ADVERSE EVENTS OR INJURY WERE REPORTED. BASED ON EVALUATION OF THE RETURNED DEVICE, THE ROOT CAUSE FOR THE MALFUNCTION WAS TEARING IN THE SILICONE PRESSURE SLEEVE DURING MANUFACTURING. PROCESS UPDATES HAVE SINCE BEEN IMPLEMENTED TO HELP PREVENT THIS FAILURE MODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19283500 ↗
• MalfunctionMay 10, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE PHYSICIAN INSERTED THE DEVICE, WHICH PASSED ALL SAFETY CHECKS AND BEGAN TREATMENT. 14 SECONDS INTO TREATMENT, THE DEVICE STOPPED AND FLASHED ERROR CODE 379. THE PHYSICIAN REMOVED THE DEVICE AND BEGAN VENTING IT. THE PHYSICIAN THEN PROCEEDED WITH A NEW DEVICE AND COMPLETED A FULL TREATMENT ON THE PATIENT. THE PATIENT WAS DISCHARGED AND NO ADVERSE EVENTS OR INJURY WERE REPORTED. BASED ON EVALUATION OF THE RETURNED DEVICE, THE ROOT CAUSE FOR THE MALFUNCTION WAS TEARING IN THE SILICONE PRESSURE SLEEVE DURING MANUFACTURING. PROCESS UPDATES HAVE SINCE BEEN IMPLEMENTED TO HELP PREVENT THIS FAILURE MODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19283497 ↗
• MalfunctionMay 10, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PROCEDURE WAS CONDUCTED IN THE OPEARTING ROOM, WHERE THE PHYSICIAN PREPPED AND DILATED THE PATIENT AND PERFORMED A D&C PRIOR TO THE ABLATION PROCEDURE. THE DEVICE WAS INSERTED, THE LINER WAS DEPLOYED, AND PRE-TREATMENT TESTS WERE PERFORMED BY THE DEVICE. AFTER THE CRYO TREATMENT STARTED, AN ERROR CODE 379 OCCURED AFTER ABOUT 35 SECONDS OF TREATMENT. THE DEVICE WAS REMOVED AND VENTED, AND THE PATIENT WAS DISCHARGED. THE ROOT CAUSE FOR THE MALFUCTION WAS INDETERMINATE, AS THE FAILURE MODE COULD NOT BE REPLICATED. ADDITIONALLY, IT WAS NOTED THAT THE SHEATH WAS RETRACTED TO 7.5 CM FOR TREATMENT IN THIS CASE, WHICH IS OUTSIDE OF THE INDICATED 6.5 CM MAXIMUM CAVITY LENGTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19283495 ↗
• MalfunctionMay 10, 2024Mechanical Jam; Mechanical Jam

  THE PHYSICIAN INITIATED TREATMENT WITH THE DEVICE AND 17 SECONDS INTO TREATMENT, THE DEVICE INDICATED ERROR CODE 377. THE DEVICE WAS REMOVED FROM THE PATIENT. VENTING WAS INITIATED BUT THE DEVICE INDICATED IT WAS NOT SAFE FOR DISPOSAL. IT WAS NOTED THAT THE PATIENT HAD NO ADVERSE EVENT AND WAS DISCHARGED. INVESTIGATION OF THE RETURNED DEVICE INDICATED THAT IMPROPER INSTALLATION OF THE GUIDE TUBE LED TO KINKING AND WEAKENING OF THE NITROUS OXIDE DELIVERY LINE AND INSUFFICIENT FLOW OF NITROUS OXIDE INTO THE LINER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19283494 ↗
• MalfunctionMay 10, 2024Problem with Software Installation; Problem with Software Installation

  THE DEVICE WAS INSERTED INTO THE PATIENT, AFTER WHICH THE PHYSICAN RE-CONFIRMED ATTACHMENT OF THE HOSE TO THE EXHAUST COLLECTION BAG. THE PHYSICIAN FOLLOWED THE PROMPTS ON THE SCREEN TO RETRACT TO THE CAVITY LENGTH AND INITIATE SYSTEM COUNTDOWN AND TREATMENT. AFTER 30 SECONDS OF TREATMENT, THE DEVICE SHOWED ERROR CODE 301. THE PATIENT WAS DISCHARGED. INVESTIGATION OF THE RETURNED DEVICE CONCLUDED THAT MANUFACTURING TEST SOFTWARE HAD BEEN LOADED ONTO THE DEVICE INSTEAD OF CONTROL SOFTWARE. A CORRECTIVE ACTION TO INCREASE DETECTION OF THE FAILURE MODE WAS IMPLEMENTED ON THE MANUFACTURING LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19283488 ↗
• MalfunctionMay 10, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  DEVICE FUNCTIONED NORMALLY AS THE PHYSICIAN FOLLOWED THE PROMPTS ON THE SCREEN AND DEVICE WAS INSERTED INTO THE PATIENT. THE PRE-TREATMENT SEQUENCE ADVANCED NORMALLY AND TREATMENT INTIATED. ALMOST IMMEDIATELY, THE LCD SCREEN DISPLAYED ERROR CODE 379. DEVICE WAS REMOVED FROM THE PATIENT AND SET ASIDE FOR FURTHER INVESTIGATION. THE PROCEDURE WAS ENDED AND THE PATIENT DID NOT RECEIVE TREATMENT. BASED ON EVALUATION OF THE RETURNED DEVICE, THE ROOT CAUSE FOR THE MALFUNCTION WAS TEARING IN THE SILICONE PRESSURE SLEEVE DURING MANUFACTURING. PROCESS UPDATES HAVE SINCE BEEN IMPLEMENTED TO HELP PREVENT THIS FAILURE MODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19283487 ↗
• MalfunctionApr 25, 2024Device Contamination with Body Fluid; Electrical Shorting; Device Contamination with Body Fluid; Electrical Shorting

  DEVICE FUNCTIONED NORMALLY AS THE PHYSICIAN FOLLOWED THE PROMPTS ON THE SCREEN AND THE DEVICE PASSED SAFETY CHECKS. AT 120 SECONDS INTO TREATMENT, THE DEVICE LCD SCREEN SHOWED ERROR CODE 003. THE DEVICE WAS REMOVED FROM THE PATIENT AND VENTED, THE PROCEDURE WAS TERMINATED, AND THE PATIENT WAS DISCHARGED. IT WAS NOTED THAT THE PATIENT WAS TREATED IN THE OPERATING ROOM UNDER GENERAL ANESTHESIA AND THAT THE PHYSICIAN HAD PERFORMED HYSTEROSCOPY AND D&C PRIOR TO THE PROCEDURE. AS THE DEVICE HAS NOT YET BEEN RETURNED, INVESTIGATION IS PENDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19178064 ↗