Genesys HTA ProCerva M006580210 (UDI 08714729809456)Recalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 08714729809456), received between May 8, 2017 and May 19, 2023 — classified as 53 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (32 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 91 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2023Fluid/Blood Leak; No Apparent Adverse Event; Fluid/Blood Leak; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PROXIMAL END OF THE SHEATH COMPONENT OF THE PROCERVA PROCEDURAL SET BROKE DURING USE. NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16963753 ↗
• MalfunctionMar 15, 2023Detachment of Device or Device Component; No Apparent Adverse Event; Detachment of Device or Device Component; No Apparent Adverse Event

  IT WAS REPORTED THE PROCERVA SHEATH END DETACHED. NO INJURIES REPORTED. IT WAS REPORTED THE PROCERVA SHEATH END DETACHED. NO INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16546941 ↗
• MalfunctionMar 8, 2023Detachment of Device or Device Component; No Apparent Adverse Event; Detachment of Device or Device Component; No Apparent Adverse Event

  IT WAS REPORTED THE PROCERVA SHEATH END DETACHED DURING USE AND HOT SALINE WAS COMING OUT. THE HOT SALINE DID NOT CONTACT THE PATIENT OR THE USER. NO INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16501135 ↗
• MalfunctionFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE SYSTEM ALERTED THE PHYSICIAN OF FLUID LOSS THREE TIMES THROUGHOUT THE TREATMENT CYCLE. THE PHYSICIAN DID NOT NOTICE A CERVICAL LEAK OF FLUID UNTIL THE THIRD ALERT WHEN THE TREATMENT CYCLE WAS ABORTED. PHYSICIAN OBSERVED FLUID ON THE CERVIX AND THE POSTERIOR OF THE VAGINAL WALL. ONCE COMPLETED, A SMALL VAGINAL BURN WAS NOTED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 16452509 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 01/10/2023 THE MANUFACTURER WAS MADE AWARE OF AN ENDOMETRIAL ABLATION PROCEDURE PERFORMED 3-4 MONTHS PRIOR TO AWARE DATE. IT WAS REPORTED THAT NINE MINUTES INTO THE 10 MINUTE ABLATION CYCLE, THE SYSTEM ALERTED USER OF FLUID LOSS. USER TERMINATED THE PROCEDURE AND NOTED THAT THE PATIENT HAD A SMALL BURN IN THE AREA OF VAGINAL CUFF. PATIENT WAS TREATED WITH NEOSPORIN AND SILVADENE CREAM. PATIENT RETURNED LATER (TIMING UNKNOWN) REPORTING DISCOMFORT WITH THE BURN, BUT NO ADDITIONAL MEDICAL INTERVENTION BEYOND TOPICAL CREAM WAS REPORTED.

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Nausea; Partial thickness (Second Degree) Burn; Sexual Dysfunction

  MAUDE report 16329341 ↗
• InjuryMay 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT EXPERIENCED A BURNING SENSATION DURING URINATION POST GENESYS HTA PROCEDURE. PHYSICIAN REPORTED NO MALFUNCTION OR ALARM BY THE SYSTEM DURING THE PROCEDURE AND NO FLUID LEAK WAS NOTED. PHYSICIAN CHARACTERIZED THE THERMAL EFFECT TO BE MINOR IN NATURE AND RECOMMENDED APPLICATION OF SILVER SULFADIAZINE TOPICAL CREAM.

  Patient problems: Burn(s); Burning Sensation

  MAUDE report 14360291 ↗
• InjuryFeb 25, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT AN HTA PROCEDURE WAS PERFORMED ON PATIENT SUFFERING FROM AUB (E). THE PATIENT WAS ACTIVELY BLEEDING AT THE TIME OF THE OPERATIVE VISIT. DURING THE DIAGNOSTIC HYSTEROSCOPY (NOT ABLATION) PHASE, THE PHYSICIAN EXPERIENCED LEAKS AT THE CERVIX THREE TIMES, NECESSITATING PLACEMENT OF FOUR INSTRUMENTS ON THE CERVIX TO ACHIEVE A CERVICAL SEAL. THE ABLATION CYCLE WAS COMPLETED SUCCESSFULLY. DURING THE COOLING PHASE, ONE OF THE FOUR INSTRUMENTS, USED TO CREATE THE CERVICAL SEAL, WAS REMOVED FROM THE CERVIX. THIS RESULTED IN HEATED INTRA-CAVITARY FLUID MIGRATION FROM THE UTERINE CAVITY AND INTO THE VAGINA, RESULTING IN AN UNINTENDED THERMAL EFFECT ON VAGINAL MUCOSA. THE PHYSICIAN TREATED THE AFFECTED AREA WITH A COOL SALINE GAUZE AND SILVER SULFADIAZINE TOPICAL CREAM.

  Patient problems: Burn(s)

  MAUDE report 13601664 ↗
• InjuryOct 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING AN HTA PROCEDURE PERFORMED IN A (B)(6) YEAR-OLD PATIENT SUFFERING FROM AUB, HOT FLUID LEAKED RESULTING IN A SECOND-DEGREE UNINTENDED THERMAL EFFECT ON HER BUTTOCK. THE PATIENT IS CURRENTLY UNDERGOING TREATMENT FOR THIS ADVERSE EVENT WHICH INVOLVES DEBRIDEMENT WITH FLAP.

  Patient problems: Burn(s)

  MAUDE report 12600531 ↗
• InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PROCEDURE A FLUID LOSS ALARM WAS DECLARED 3 MINUTES INTO THE ABLATION CYCLE. DOCTOR DID NOT SEE ANY EVIDENCE FLUID LEAK. AFTER THE THIRD ALARM DOCTOR CHOSE TO ABORT THE PROCEDURE. DOCTOR NOTICED ONE SMALL AREA OF UNINTENDED THERMAL EFFECT ON POSTERIOR VAGINAL MUCOSA, WHICH WAS TREATED WITH VAGINAL CREAM (EXACT BRAND UNKNOWN) AND A SIMILAR SIZE AREA ON PERINEUM, WHICH WAS TREATED TOPICALLY WITH SILVADENE CREAM. PATIENT DISCHARGED THE SAME DAY.

  Patient problems: Burn(s)

  MAUDE report 12478623 ↗
• InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT AN HTA PROCEDURE WAS PERFORMED IN AN APPROXIMATELY (B)(6) PATIENT SUFFERING FROM AUB. THE PATIENT WAS ALSO SUFFERING FROM DIABETES AND EPILEPSY. NO ALARMS OR LEAKS WERE PRESENT; HOWEVER THE PROCEDURE SHEATH TUBING WAS IN CONTACT WITH THE PATIENT'S BUTTOCK DURING THE ABLATION CYCLE. UPON COMPLETION OF THE PROCEDURE, DOCTOR NOTICED A QUARTER SIZE AREA OF UNINTENDED THERMAL EFFECT ON THE AREA OF CONTACT BETWEEN THE BUTTOCK AND THE PROCEDURE SHEATH TUBING, WHICH WAS TREATED WITH SILVADENE CREAM. PATIENT WAS DISCHARGED.

  Patient problems: Burn(s)

  MAUDE report 12478592 ↗
• InjuryJun 23, 2021Fluid/Blood Leak; Insufficient Device Problem Information; Fluid/Blood Leak; Insufficient Device Problem Information

  DURING A GENESYS HTA ABLATION CYCLE, THE SYSTEM SOUNDED AN ALARM, INDICATING A FLUID LOSS OF 10 ML, AND APPROPRIATELY STOPPED THE PROCEDURE. THE PHYSICIAN REPOSITIONED THE TENACULUM AND ELECTED TO CONTINUE WITH THE ABLATION CYCLE, WHICH WAS COMPLETED WITHOUT ANY INCIDENTS. SHORTLY AFTER THE PROCEDURE, THE PHYSICIAN INFORMED THE MANUFACTURER THAT THE PATIENT EXPERIENCED UNINTENDED THERMAL EFFECT ON LEFT AND RIGHT LABIA, TREATED WITH APPLICATION OF CREAM.

  Patient problems: Burn(s)

  MAUDE report 12053333 ↗
• InjuryApr 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A GENESYS HTA PROCERVA PROCEDURE SET WAS USED IN A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN PERFORMED A POLYPECTOMY BEFORE THE PROCEDURE. AFTER DEVICE INSERTION, A SEAL INTEGRITY CHECK CYCLE WAS INITIATED AND INDICATED A LEAK. PHYSICIAN APPLIED A SECOND TENACULUM AND THE LEAK WAS STOPPED. ABLATION WAS INITIATED AND COMPLETED. UPON DEVICE REMOVAL AN AREA OF UNINTENDED THERMAL EFFECT WAS OBSERVED ON PATIENT'S LEFT LABIA. NO SUCH EFFECT WAS OBSERVED ANYWHERE ELSE. AFFECTED AREA WAS MANAGED USING TOPICAL SILVADENE CREAM.

  Patient problems: Burn(s)

  MAUDE report 11704578 ↗
• InjuryApr 2, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A GENESYS HTA PROCERVA PROCEDURE SET WAS USED IN A PROCEDURE. DURING THE PROCEDURE A FLUID LOSS ALARM WAS DECLARED APPROXIMATELY 2 MINUTES INTO THE ABLATION CYCLE. DR. ATTEMPTED TO SEAL THE CERVIX USING AN ADDITIONAL TENACULUM. DURING THIS ATTEMPT, AN ADDITIONAL VOLUME OF INTRA-CAVITARY (PREVIOUSLY HEATED) FLUID ESCAPED FROM THE UTERINE CAVITY AND SPILLED ONTO PATIENT'S VAGINAL MUCOSA AND PERINEUM, INFLICTING UNINTENDED THERMAL EFFECT ON THESE STRUCTURES. THE THERMAL DAMAGE WAS GRADED AS SECOND DEGREE AND WAS MANAGED WITH TOPICAL SILVADENE CREAM AS WELL AS REFERRAL TO A SPECIALIST.

  Patient problems: Burn(s)

  MAUDE report 11609061 ↗
• InjuryNov 18, 2020Fluid/Blood Leak; Appropriate Device Problem Term/Code Not Available; Fluid/Blood Leak; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT GENESYS HTA PROCERVA PROCEDURE SETS WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN DIALATED TO 23 FR AND WAS ASSURED THAT SHE GOT A GOOD SEAL AND DID NOT SEE ANY SIGNIFICANT FLUID LOSS BEFORE INITIATING THE ABLATION PROCESS. SIX MINUTES INTO PROCEDURE, THE PHYSICIAN STATED THAT HOT FLUID RUSHED OUT AND BURNED THE PATIENT'S VAGINA. THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE AND BEGUN COOLING PROCESS. REPORTEDLY, ERROR MESSAGE CHECK FOR FLUID LOSS APPEARED ON THE CONSOLE. THE PATIENT WAS REFERRED TO BURN PHYSICIAN TO CONSULT ON BURN SITE.

  Patient problems: Burn(s)

  MAUDE report 10860333 ↗
• MalfunctionNov 6, 2020Filling Problem; Appropriate Device Problem Term/Code Not Available; Filling 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, THE PHYSICIAN COULD NOT GET A SEAL AFTER DOING A RESECTOR CASE ON THE SAME PATIENT. IT WAS SUSPECTED THAT THERE WAS OVER DILATION OF CERVIX WITH SCOPE PRIOR TO HTA CASE. REPORTEDLY, NO ERROR MESSAGE APPEARED ON THE CONSOLE, IT JUST COULD NOT SEAL THE CERVIX. THE INTEGRITY CHECK WOULD NOT ALLOW THEM TO PROCEED. THE PHYSICIAN THEN DECIDED TO ABORT THE PROCEDURE FOLLOWING THE ISSUE WITH THE DEVICE. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10799988 ↗
• MalfunctionNov 5, 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 GENESYS HTA PROCERVA PROCEDURE SETS WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE CONTROLLER WENT FROM THE CERVICAL SEAL SCREEN TO RELEASING CASSETTE. CIRCULATOR EJECTED THE CASSETTE AND THE STAFF OPENED A SECOND DEVICE. REPORTEDLY, THE SECOND DEVICE ALSO MULFUNCTIONED DURING THE SEALING THE TEST AND WAS NOT HEATING UP SO THE PHYSICIAN THEN DECIDED TO ABORT THE CASE. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10793801 ↗
• MalfunctionNov 5, 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 GENESYS HTA 115V CONTROL UNIT WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE CONTROLLER WENT FROM THE CERVICAL SEAL SCREEN TO RELEASING CASSETTE. CIRCULATOR EJECTED THE CASSETTE AND THE STAFF OPENED A SECOND DEVICE. REPORTEDLY, THE SECOND DEVICE ALSO MALFUNCTIONED DURING THE SEALING THE TEST AND WAS NOT HEATING UP SO THE PHYSICIAN THEN DECIDED TO ABORT THE CASE. THERE WERE NO PATIENT COMPLICATION 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 Consequences Or Impact To Patient

  MAUDE report 10791994 ↗
• MalfunctionOct 12, 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 ON (B)(6) 2020 THAT A GENESYS HTA PROCERVA PROCEDURE SETS WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PROCEDURE WAS DONE UNDER GENERAL ANESTHESIA. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN TRIED TO GET A SEAL THREE TIMES AND WAS NOT SUCCESSFUL. THE CERVIX WAS ALSO CHECK AND A SECOND SINGLE TOOTH TENACULUM WAS USED BUT STILL UNSUCCESSFUL. UNDER VISUALIZATION THE PHYSICIAN DID NOT SEE A LEAK AND FELT CONFIDENT THAT THERE WAS NO LEAK. HOWEVER, THE SYSTEM WOULD NOT LET THEM PROCEED. 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 10661701 ↗
• MalfunctionSep 25, 2020Temperature Problem; Appropriate Device Problem Term/Code Not Available; Temperature Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 11, 2020 THAT A GENESYS HTA PROCEDURE SET WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS NOT HEATING UP. THE STAFF TRIED A SECOND DEVICE BUT THE SAME ISSUE OCCURRED. THE PROCEDURE WAS CANCELED 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 10586711 ↗
• MalfunctionSep 25, 2020Temperature Problem; Appropriate Device Problem Term/Code Not Available; Temperature Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 11, 2020, THAT A GENESYS HTA PROCEDURE SET WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS NOT HEATING UP. THE STAFF TRIED A SECOND DEVICE, BUT THE SAME ISSUE OCCURRED. THE PROCEDURE WAS CANCELED 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 10586002 ↗
• MalfunctionSep 21, 2020Defective Device; Appropriate Device Problem Term/Code Not Available; Defective Device; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT GENESYS HTA PROCERVA PROCEDURE SETS WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SYSTEM FAULTED 7 MINUTES INTO PROCEDURE. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATION 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 10559560 ↗
• MalfunctionSep 18, 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 AUGUST 24, 2020 THAT A GENESYS HTA PROCEDURE SET WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. REPORTEDLY, THE PATIENT HAD RECURRENT BLEEDING, POLYP, AND ADENOMYOSIS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PATIENT WAS IN THE LITHOTOMY POSITION, AND A WEIGHTED SPECULUM WAS PLACED TO THE POSTERIOR FOURCHETTE. THE HYSTEROSCOPE WAS INSERTED INTO THE CAVITY WITH SOME DIFFICULTY DUE TO THE ACTIVE BLEEDING. THE PHYSICIAN PROCEEDED, COMPLETED DILATION AND CURETTAGE, AND SPECIMEN WAS SENT TO PATHOLOGY. THE PHYSICIAN STARTED THE HTA PROCEDURE, AND AFTER 3 MINUTES INTO ABLATION, THE MACHINE GAVE A SAFETY ALARM OF LEAKING FLUID OR UTERINE EXPANSION. THE PROCEDURE HAD TO BE ABORTED. THE PATIENT WAS GIVEN PARACERVICAL BLOCK WITH EPI TO HELP WITH THE BLEEDING, AND PAIN. THE PATIENT CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE. REPORTEDLY, THE PATIENT WILL BE REVIEWED BY THE PHYSICIAN AFTER 2 WEEKS. 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 10553109 ↗
• MalfunctionSep 16, 2020Defective Device; Appropriate Device Problem Term/Code Not Available; Defective Device; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT GENESYS HTA PROCERVA PROCEDURE SETS WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN WAS UNABLE TO COMPLETE THE CASE DUE TO SYSTEM FAILURE. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATION 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 10539417 ↗
• MalfunctionSep 8, 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 THAT GENESYS HTA PROCERVA PROCEDURE SETS 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 COOL DOWN 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 D

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10501520 ↗
• InjuryJan 10, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019, THAT A GENESYS HTA PROCERVA PROCEDURE SET WAS USED IN A HYDROTHERMAL ABLATION PROCEDURE IN THE UTERUS PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE PHYSICIAN NOTED SOME FLUID LEAKING FROM THE PATIENT'S CERVIX DURING ABLATION CYCLE. THE PHYSICIAN REMOVED THE SHEATH CAUSING AN EXTERNAL BURN TO THE PATIENT. REPORTEDLY, NO FLUID LOSS ALARM WAS NOTED ON THE CONSOLE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. AN ADDITIONAL ATTEMPT HAS ALSO BEEN MADE TO OBTAIN FOLLOW UP EVENT DETAILS WITH NO RESPONSE FROM THE CLINICIAN.

  Patient problems: Burn(s)

  MAUDE report 9576272 ↗