Genesys HTA System M006580010Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 08714729809326), received between Jan 11, 2018 and Nov 20, 2020 — classified as 4 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (13 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 18, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2020Power Problem; Appropriate Device Problem Term/Code Not Available; Power Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT GENESYS HTA 115V CONTROL UNIT WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, A HTA MACHINE DID NOT POWER UP FOR THE SCHEDULED HYSTEROSCOPY WITH HYDROTHERMAL ABLATION PROCEDURE. REPORTEDLY, NO ERROR MESSAGE OR CODE APPEARED ON THE CONSOLE. THEY TRIED A NEW CABLE AND ATTEMPTED ALL TROUBLESHOOT BUT THE ISSUE WAS NOT RESOLVED. THE PROCEDURE WAS ABORTED DUE TO NOT HAVING A REPLACEMENT DEVICE. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10874610 ↗
• MalfunctionOct 23, 2020Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 1, 2020 THAT A GENESYS HTA 115V CONTROL UNIT WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A LEAK ERROR MESSAGE WAS RECEIVED. REPORTEDLY, THERE WERE NO VISIBLE FLUID LEAKS NOTED. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10725712 ↗
• MalfunctionSep 29, 2020Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GENESYS HTA CONTROLLER WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE CONTINUOUSLY DISPLAYED A "CARTRIDGE ERROR" ON 3 CASSETTES USED. REPORTEDLY, THE HTA CONTROLLER HAS CAUSED THE ISSUE. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENT REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10601653 ↗
• MalfunctionSep 28, 2020Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A GENESYS HTA 115V CONTROL UNIT WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE UNIT WAS SHOWING CARTRIDGE ERROR. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10596878 ↗
• InjurySep 25, 2020Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A GENESYS HTA CONTROLLER AND HTA PROCEDURE SET WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LABIA APPEARED TO HAVE A FIRST DEGREE BURN. REPORTEDLY, THERE WAS NO ISSUE WITH THE DEVICE AND NO ALARMS WERE DETECTED DURING THE PROCEDURE. THE BURN WAS TREATED WITH OINTMENT AT THE PHYSICIAN'S OFFICE.

  Patient problems: Burn(s)

  MAUDE report 10587371 ↗
• MalfunctionSep 9, 2020Device Alarm System; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT GENESYS HTA 115V CONTROL UNIT WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN MENTIONED THAT THEY ARE UNSURE WHERE THE FLUIDS ARE GOING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10511289 ↗
• MalfunctionSep 8, 2020Device Alarm System; Device Displays Incorrect Message; Power Problem; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Device Displays Incorrect Message; Power Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT GENESYS HTA 115V CONTROL UNIT WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING HYSTEROSCOPY MODE, THE CONSOLE WENT BLACK WITHOUT WARNING, REBOOTED ITSELF AS IF THE ON AND OFF SWITCH HAD BEEN PRESSED AND RENDERED THE CASSETTE FAULTY. REPORTEDLY, THE PLUG BEING USED HAD A PIECE OF TAPE OVER IT. HOWEVER, THE PROCEDURE WAS CONTINUED WITH THE NEW CASSETTE AND DURING ABLATION MODE A BLACK SMUDGE THAT GREW QUICKLY WAS NOTICED ON THE END OF THE SCOPE. THE PHYSICIAN DID NOT HAVE VISUALIZATION OF THE CAVITY AND WENT INTO OVERRIDE COOLDOWN MODE. THE SEAL AND PLACEMENT WERE VERIFIED AND INITIATED ABLATION MODE. ABOUT TWO MINUTES INTO THE PROCEDURE, THE CONSOLE SHOWED AN ALARM OF NO FLOW AND INSTRUCTED TO CHECK FOR TISSUE OBSTRUCTION AND KINKS IN THE TUBING. THE UTERUS HAD CRAMPED DOWN OVER THE PROCEDURE SHEATH AND SEVERAL CLOTS WERE PRESENT IN THE TUBING, THE PHYSICIAN IDENTIFIED THIS AS THE CAUSE OF THE OBSTRUCTION AND DECIDED TO CONTINUE WITH THE ABLATION. AT ABOUT SIX MINUTES INTO THE ABLATION, THERE WAS AN ALARM OF FLUID LOSS OF 64CC/MIN. THE BAG OF FLUID WAS MANUALLY CALCULATING A ZERO DEFICIT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10501357 ↗
• MalfunctionAug 19, 2020Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A GENESYS HTA 115V CONTROL UNIT WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AN INCORRECT FLUID (SOLUTION) ERROR MESSAGE WAS RECEIVED. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10428064 ↗
• MalfunctionAug 10, 2020Insufficient Cooling; Appropriate Device Problem Term/Code Not Available; Insufficient Cooling; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A GENESYS HTA 115V CONTROL UNIT WAS USED IN A PROCEDURE PERFORMED ON UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE MACHINE WOULD NOT COOL DOWN. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10384941 ↗
• MalfunctionJul 27, 2020Installation-Related Problem; Appropriate Device Problem Term/Code Not Available; Installation-Related Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GENESYS HTA CONTROLLER WAS USED TO PERFORM A HYDROTHERMAL ABLATION PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT WAS UNDER ANESTHESIA. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE PHYSICIAN WAS PRIMING THE MACHINE AND AN ERROR MESSAGE "CASSETTE FAILED" APPEARED. A SECOND CASSETTE WAS USED THE PHYSICIAN WAS UNABLE TO GAIN PRESSURE. THE HTA CASSETTE WAS REPRIMED AND IT FAILED FOR THE THIRD TIME. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10327276 ↗
• MalfunctionApr 14, 2020Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A GENESYS HTA 115V CONTROL UNIT WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE CONSOLE SHOWED ERROR CODE 10 FAST PUMP. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT AND HOW THE PROCEDURE WAS COMPLETED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9957310 ↗
• MalfunctionMar 11, 2020Device Alarm System; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 24, 2019 THAT A GENESYS 115V HTA CAPITAL WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING THE COMPLAINANT, DURING THE PROCEDURE, THE CONSOLE SHOWS FLUID LOSS ERROR TWICE AND A CASSETTE ERROR ONCE. THE PROCEDURE WAS CANCELLED. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9819799 ↗
• MalfunctionDec 23, 2019Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON DECEMBER 3, 2019, THAT A GENESYS HTA CAPITAL WAS USED IN A HYDROTHERMAL ABLATION PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, ERROR CODE TWENTY FIVE APPEARED ON THE CONSOLE. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9510915 ↗
• InjuryDec 11, 2019Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A GENESYS HTA CAPITAL WAS USED DURING A ENDOMETRIAL ABLATION PROCEDURE IN THE UTERUS PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A BURN. REPORTEDLY, NO ALARMS OR ERROR MESSAGE WAS NOTED DURING THE PROCEDURE. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. AN ADDITIONAL ATTEMPT HAS BEEN MADE TO OBTAIN FOLLOW UP EVENT DETAILS WITH NO RESPONSE FROM THE CLINICIAN.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 9450262 ↗
• MalfunctionNov 19, 2019Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 28, 2019 THAT A GENESYS HTA CAPITAL WAS USED IN A HYDROTHERMAL ABLATION PROCEDURE IN THE UTERUS PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A FAULTY CASSETTE ERROR APPEARED ON THE CONSOLE. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9341946 ↗
• MalfunctionNov 12, 2019Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 16, 2019 THAT A GENESYS HTA CONTROL UNIT WAS USED IN A HYDROTHERMAL ABLATION PROCEDURE IN THE UTERUS PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, ERROR MESSAGE NOT A GOOD CERVICAL SEAL APPEARED ON THE CONSOLE. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9309332 ↗
• MalfunctionNov 12, 2019Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 16, 2019 THAT A GENESYS HTA CONTROL UNIT WAS USED IN A HYDROTHERMAL ABLATION PROCEDURE IN THE UTERUS PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, ERROR MESSAGE NOT A GOOD CERVICAL SEAL APPEARED ON THE CONSOLE. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9309325 ↗
• MalfunctionNov 5, 2019Device Alarm System; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 9, 2019 THAT A GENESYS HTA CONTROL UNIT WAS USED IN A HYDROTHERMAL ABLATION PROCEDURE IN THE UTERUS PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, A FLUID LEAK ALARM WAS NOTED ON THE CONSOLE. A SECOND CASSETTE WAS USED AND ERROR MESSAGE 11 APPEARED ON THE SCREEN. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9281259 ↗
• MalfunctionOct 29, 2019Poor Quality Image; Appropriate Device Problem Term/Code Not Available; Poor Quality Image; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A GENESYS HTA CONTROL UNIT WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE AND OUTSIDE THE PATIENT, THE SCREEN OF THE CONSOLE STARTED FLASHING DIFFERENT COLORS THEN WENT BLACK. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9250929 ↗
• MalfunctionOct 29, 2019Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A GENESYS HTA CONTROL UNIT WAS USED IN A HYDROTHERMAL ABLATION PROCEDURE IN THE UTERUS PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, ERROR MESSAGE NOT A GOOD CERVICAL SEAL APPEARED ON THE CONSOLE. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9250885 ↗
• MalfunctionOct 29, 2019No Display/Image; Appropriate Device Problem Term/Code Not Available; No Display/Image; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A GENESYS HTA CONTROL UNIT WAS USED IN A HYDROTHERMAL ABLATION PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE SCREEN OF THE CONSOLE WAS BLANK. THE UNIT WAS REBOOTED BUT THE ISSUE PERSIST. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9250784 ↗
• InjuryOct 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A GENESYS HTA CONSOLE AND PROCEDURE SET WERE USED DURING A HYDROTHERMAL ABLATION PROCEDURE IN THE UTERUS PERFORMED ON (B)(6) 2019. REPORTEDLY THE PROCEDURE WAS DONE UNDER GENERAL ANESTHESIA. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A BURN FOLLOWING THE PROCEDURE. THERE WERE NO ALARMS NOTED ON THE CONSOLE DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THE PATIENTS CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OKAY. AN ADDITIONAL ATTEMPT HAS BEEN MADE TO OBTAIN FOLLOW UP EVENT DETAILS WITH NO RESPONSE FROM THE CLINICIAN.

  Patient problems: Burn(s)

  MAUDE report 9197911 ↗
• MalfunctionJul 3, 2018Smoking; Smoking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 7, 2018 THAT A GENESYS HYDROTHERMABLATION CONTROLLER WAS USED IN A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING ABLATION PHASE, WHEN THE FLUID TEMPERATURE HEATED TO 80 DEGREES CELSIUS AND REACHED 100 DEGREES CELSIUS, A FAULTY CASSETTE ALARM WAS DETECTED. THE STAFF TRIED TO INITIATE COOL DOWN MODE BUT THE CONTROLLER WAS NOT RESPONDING. A PLASTIC BURNING SMELL WAS NOTED AND SMOKE WAS COMING OUT FROM WHERE THE CASSETTE WAS ENGAGED. THE MACHINE WAS RESTARTED AND THE PHYSICIAN WAITED 5 MINUTES FOR FLUID TO COOL DOWN. A BULB SYSTEM WITH ROOM TEMPERATUE SALINE WAS USED TO IRRIGATE THE AREA. THEE PROCEDURE WAS ABORTED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7657982 ↗
• InjuryJan 11, 2018Device Alarm System; Device Alarm System

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. ASSOCIATED MFR REPORT #3005099803-2017-03936 PERTAINS TO THE GENESYS HYDROTHERMABLATION PROCERVA PROCEDURE SET. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 29, 2017 THAT A GENESYS HYDROTHERMABLATION ENDOMETRIAL ABLATION SYSTEM WAS USED IN A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6) 2017 UNDER GENERAL ANESTHESIA. ACCORDING TO THE COMPLAINANT, AROUND THREE MINUTES INTO THE ABLATION, THE WATER WAS SEEN GUSHING OUT OF THE CERVIX RESULTING IN THE CERVIX AND VAGINA BEING BURNED. THEY TOOK FOUR LITERS OF SALINE AND POURED IT OVER THE BURNT AREA TO COOL IT DOWN. IT WAS TREATED WITH BURN CREAM AFTER THEY HAD COOLED IT DOWN. PATIENT WAS THEN SENT HOME. ***ADDITIONAL INFORMATION RECEIVED ON DECEMBER 21, 2017*** REPORTEDLY, THE CONSOLE DID NOT GIVE ANY ALARM OR ERROR MESSAGE UPON THE OCCURRENCE OF A CERVICAL LEAK. ***ADDITIONAL INFORMATION RECEIVED ON JANUARY 8, 2018*** REPORTEDLY, THE CONSOLE HAS NOT BEEN USED SINCE THE EVENT. THE PATIENT IS REPORTED TO HAVE "HEALED OKAY."

  Patient problems: Burn(s)

  MAUDE report 7181794 ↗