Acessa ProVu System 7300Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 15420045515246), received between Apr 21, 2023 and Sep 24, 2026 — classified as 1 death, 34 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (2 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Insufficient Device Problem Information

  Patient problems: Pelvic Pain

  MAUDE report 50884622 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient received an Acessa Procedure on (b)(6) 2026, in which no concerns were observed during the procedure. Later the patient was admitted to the emergency room on (b)(6) 2026 due to exibiting abdominal pain, diarrhea, vomiting, fever and chills. Patient received 2 CT Scans that returned negative. Patient had modest elevated white blood count and was diagnosed with bacteremia, post op infection more specifically a gastrointestinal infection. Patient was reported as received antibiotics pre procedure and post procedure as well. Patient was later reported as doing well and no further treatment required. No other information available.

  Patient problems: Bacterial Infection; Chills; Diarrhea; Fever; Nausea; Vomiting

  MAUDE report 50083742 ↗
• InjuryJun 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED AN ACESSA PROCEDURE ON (B)(6) 2026, IN WHICH 3 FIBROIDS OF UNKNOWN SIZE WERE ABLATED. NO INJURIES NOR MEDICAL INTERVENTION WAS REPORTED REQUIRED DURING THE PROCEDURE AND THE PATIENT DID NOT HAD ANY PREVIOUS PROCEDURES NOR CONCOMITANT DEVICES USED. PATIENT HAD A PREVIOUS HISTORY OF HIGH BLOOD PRESSURE TREATED WITH AMLODIPINE AND OBSTRUCTIVE SLEEP APNEA. ON APRIL 23RD, IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM DUE TO PLEURAL EFFUSION. THE TREATING PHYSICIAN FROM THE CASE COULD NOT DETERMINE A SPECIFIC ROOT CAUSE AND LINKAGE BETWEEN THE ACESSA PROCEDURE AND THE PLEURAL EFFUSION OBSERVED. THE PATIENT CONSULTED A PULMONOLOGIST THAT MENTIONED TO THE PATIENT WHICH IN HER OWN WORDS ¨ THAT DURING PROCEDURES INVOLVING HEAT TRANSFER THERE COULD BE PLEURAL EFFUSION AFTERWARDS¨. PATIENT WAS ADMITTED TO THE HOSPITAL AND KEPT FOR OBSERVATION RECEIVING CONTROL CHEST X-RAYS. NO MEDICATION WAS REPORTED TO HAVE BEEN ADMINISTERED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Pleural Effusion

  MAUDE report 25366507 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT RECEIVED AN ACESSA PROCEDURE, THE PROCEDURE WAS REPORTED AS UNEVENTFUL AND THE SURGEON NOTICED A MARK ON THE BLADDER. AT THE TIME OF THE PROCEDURE, IT WAS REPORTED THAT A UROLOGY TEAM CONSISTING OF SURGEON, UROLOGIST AND SURGEON PROCTOR WERE PRESENT DURING THE PROCEDURE AND AGREED THAT IT WAS NOT LIKELY CAUSED BY THE ACESSA PROCEDURE. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT HAD REPORTED INCREASED URINARY FREQUENCY AND THAT NO FOLLOW UP TREATMENT WAS REQUIRED. ON APRIL 17TH, 2026, NEW INFORMATION WAS RECEIVED ON THE CASE. THE TREATING PHYSICIAN REPORTED THAT SHE ¨NOW BELIEVES THAT THE MARK OBSERVED HAD BEEN A THERMAL SPREAD AND THAT DURING A CYSTOSCOPY IT WAS OBSERVED SPREAD THROUGH THE BLADDER¨. PATIENT RECEIVED A FOLEY CATHETER FOR 1 WEEK AND WAS PLACED ON ANTIBIOTICS. PATIENT REQUIRED MULTIPLE VISITS FOR URINATION AND PAIN AND THEN HAD TO GO BACK TO THE UROLOGIST MONTHS AFTER FOR PAIN DURING URINATION. NO OTHER INFORMATION COULD BE OBTAINED.

  Patient problems: Burn(s); Pain

  MAUDE report 25149746 ↗
• InjuryApr 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED AN ACESSA PROCEDURE BACK IN (B)(6) 2025 THE EXACT DATE IS UNKNOWN. THE PHYSICIAN REPORTED THAT AT THE TIME A PEDUNCULATED FIBROID HAD BEEN LEFT FOR LATER REMOVAL. THE PATIENT RETURNED ON AN UNKNOWN DATE FOR THE REMOVAL OF THE PEDUNCULATED FIBROID AND AT THE TIME OF THAT SURGERY THE PHYSICIAN OBSERVED THAT THE SEROSAL LAYER OF THE UTERUS HAD A TEAR FROM THE PREVIOUS PROCEDURE AND SUTURE THE TEAR OF THE SEROSA LAYER WITHOUT COMPLICATIONS. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 24849077 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED AN ACESSA PROCEDURE ON AN UNKNOWN DATE. LATER IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A UTERINE RUPTURE. NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 24505963 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED AN ACESSA PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE THE CUSTOMER EXPERIENCED ISSUES WITH THE 3D GUIDANCE AND THE LINES IN THE IMAGE WERE POOR AND INTERMITTENT FOR WHICH THE ULTRASOUND HANDPIECE WAS EXCHANGED (2 ULTRASOUND DEVICES USED) BUT THIS DIDN´T FIX THE ISSUE. PHYSICIAN DECIDED TO CONTINUE WITH THE PROCEDURE WITHOUT THE 3D GUIDANCE. ADDITIONAL INFORMATION WAS RECEIVED IT WAS REPORTED THAT THE CUSTOMER HAD PREVIOUSLY DROPPED THE TABLETOP FIELD GENERATOR (TTFG) ON A PREVIOUS PROCEDURE AND THAT THEY HAD USED IT DURING THIS PROCEDURE.THE PROCEDURE AT THE TIME HAD BEEN REPORTED TO BE COMPLETED WITHOUT PROBLEMS. THE PATIENT WAS READMITTED TO THE HOSPITAL ON A LATER DATE AND A BOWEL INJURY WAS FOUND. NO OTHER INFORMATION COULD BE OBTAINED.

  Patient problems: Insufficient Information

  MAUDE report 24461811 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED AN ACESSA PROCEDURE IN 2023 ON AN UNKNOWN DATE. THE PATIENT BECAME PREGNANT THIS PAST YEAR AND HAD A SPONTANEOUS POSTERIOR UTERINE RUPTURE. PATIENT IS DOING WELL. PRETERM PREMATURE RUPTURE OF MEMBRANES HAPPENED AT 35 WEEKS AROUND MID-(B)(6), THE EXACT DATE IS UNKNOWN, AND PATIENT RECEIVED A C-SECTION DUE TO BREECH AND THE POSTERIOR RUPTURE WAS FOUND AT THE TIME OF THE C-SECTION. BOTH BABY AND PATIENT HAVE BEEN REPORTED AS DOING WELL.

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

  MAUDE report 24349655 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A NOVASURE AND ACESSA PROCEDURE ON (B)(6) 2025, AND PATIENT PRESENTED WITH LOW GRADE FEVER ON (B)(6) 2025. THE PHYSICIAN PERFORMED AN ULTRASOUND AND NOTES AIR AND FLUID FOUND WITHIN THE ONE 4 CM FIBROID THAT HAD 3 ABLATIONS. THE NOVASURE PROCEDURE WAS PERFORMED FIRST FOLLOWED BY THE ACESSA PROCEDURE, NO COMPLICATIONS WERE NOTED WITH EITHER OF THE PROCEDURES. PATIENT IS IN THE HOSPITAL NOW FOR OBSERVATION. PER A CLINICAL DISCUSSION THE PATIENT WAS A 47-YEAR-OLD WHO HAD A ACESSA PROCEDURE HAD A4 TO 5-CENTIMETER TYPE 5 SEB SEROSAL FIBROID TREATED WITH APPROXIMATELY 4 ACTIVATIONS WITH NO CONCERNS IMMEDIATELY PRIOR TO ACCESS OF THE PATIENT HAD A NOVASURE PROCEDURE AGAIN WITH NO OBVIOUS COMPLICATIONS. APPROXIMATELY 10 DAYS LATER THE PATIENT WAS READMITTED WITH PAIN AND CT SCAN SHOWED A 4 BY 6 CENTIMETER ENHANCING FLUID COLLECTION. THE PATIENT IS NOT FEBRILE OR TENDER. AN ULTRASOUND CODE A SIMILAR FLUID COLLECTION HOWEVER, THE RADIOLOGIST WAS UNSURE IF THIS REPRESENTED AN ABSENCE. MRI IS ORDERED BUT NOT COMPLETED YET. THE PHYSICIAN WAS UNCERTAIN IF PROPHYLACTIC ANTIBIOTICS HAD BEEN ADMINISTERED PRIOR TO THE PROCEDURE. THE DISCUSSION WITH THE PHYSICIAN

  Patient problems: Fever

  MAUDE report 23990397 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ACESSA PROCEDURE IT WAS REPORTED THAT THERE IS AN UTERINE THERMAL BURN. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 23976836 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED FOR PAIN 10 DAYS POST ACESSA PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS. THERE WAS NO BLEEDING BUT A LOT OF FIBROIDS. PATIENT WENT HOME THAT DAY WITH NO ISSUES. PER A CLINICAL DISCUSSION THE PATIENT IS A 42-YEAR-OLD WHO HAD FOUR TO FIVE FIBROIDS THAT WERE TREATED. THESE WERE APPROXIMATELY IN THE 4-CENTIMETER RANGE WITH MULTIPLE APPLICATIONS OF RADIO FREQUENCY ENERGY. THE PATIENT RETURNED TO THE HOSPITAL EMERGENCY ROOM APPROXIMATELY 10 DAYS LATER COMPLAINING OF PAIN CT SCAN SHOWED A 3.5 CM DEFECT IN THE ANTERIOR MYOMETRIUM COMPARABLE TO COAGULATIVE NECROSIS. THERE WAS NO FREE FLUID, AND THERE WAS SOME QUESTION AS TO WHETHER THIS DEFECT COMMUNICATED WITH THE ENDOMETRIAL CAVITY. THE WHITE BLOOD COUNT WAS NORMAL, AND THE PATIENT REMAINED STABLE WITH NO REBOUND TENDERNESS. THERE WAS NO EVIDENCE OF INFECTION AND ANTIBIOTICS WERE NOT STARTED. AFTER 2 DAYS IN THE HOSPITAL, THE PATIENT WAS IMPROVING AND FEELING BETTER AND WAS DISCHARGED HOME. PROPHYLACTIC ANTIBIOTICS WERE NOT USED. NO CONCOMITANT PROCEDURES WERE DONE. DISCUSSION OF THE USE OF PROPHYLACTIC ANTIBIOTICS IN THE CLINICAL TRIAL OCCURRED AND NOTED THIS MAY BE REASONAB

  Patient problems: Necrosis; Pain

  MAUDE report 23976797 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ACESSA PROCEDURE ON (B)(6) 2025, THE PHYSICIAN TREATED 6 PEDUNCULATED FIBROIDS WITH MORE THAN 50% STALK. AT ONE POINT DURING THE PROCEDURE DISCOLORATION AND BLANCHING OF THE ABDOMINAL WALL WAS OBSERVED AND CONFIRMED. ANOTHER SURGEON WAS BROUGHT INTO THE ROOM AND CONFIRMED NO DAMAGE TO BLADDER OR OTHER STRUCTURES IN THE BODY. PATIENT REMAINED IN HOSPITAL WITH A FOLEY CATHETER TO MONITOR THE BLADDER UNTIL THE END OF THE WEEK. NO FURTHER TREATMENT PROVIDED TO THE PATIENT.

  Patient problems: Burn(s)

  MAUDE report 23921950 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ONGOING PERSISTENT UTERINE BLEEDING FOLLOWING AN ACESSA PROCEDURE PERFORMED ON (B)(6) 2025. THE BLEEDING BEGAN A FEW DAYS AFTER THE PROCEDURE AND PROGRESSIVELY WORSENED. MULTIPLE CT SCANS AND ULTRASOUNDS WERE PERFORMED WITH NORMAL RESULTS, AND THE PHYSICIAN DOES NOT BELIEVE THERE WAS ANY OPERATIVE COMPLICATIONS. THERE IS NO INFECTION OR ABDOMINAL BLEEDING IDENTIFIED. THE PATIENT HAD RECURRENT EMERGENCY ROOM VISITS DUE TO CRAMPING AND HEAVY MENSTRUAL TYPE SYMPTOMS. ON (B)(6) 2025, THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL, STARTED ON HIGH DOSE ORAL ESTROGEN AND RECEIVED TWO UNITS OF BLOOD VIA TRANSFUSION. THE PATIENT IS IN GOOD CONDITION AFTER THE ADDITIONAL TREATMENT. ADDITIONAL INFORMATION RECEIVED: THE PATIENT PRESENTED ABOUT 7 DAYS AFTER THE ACESSA PROCEDURE AND HAD ABOUT SIX 2-4 CM MYOMAS TREATED. THE PATIENT HAD BLEEDING AND PAIN AND WAS ADMITTED TO THE HOSPITAL AND RECEIVED TWO UNITS OF BLOOD. AFTER THIS, THE PATIENT HAD D&C HYSTEROSCOPY WITH POLYPECTOMY. THE PATIENT IS STILL HAVING THE PAIN TREATED WITH GABAPENTIN AND ULTRAM. THE MAGNETIC RESONANCE ANGIOGRAPHY IMAGING HAS BEEN NORMAL, AND THE CT SCAN SHOWED NO ARTERIOVENOUS MALF

  Patient problems: Abdominal Cramps; Bacterial Infection; Hemorrhage/Blood Loss/Bleeding; Intermenstrual Bleeding

  MAUDE report 23657635 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, AN AFRICAN AMERICAN FEMALE PATIENT, UNKNOWN AGE WAS TREATED WITH A SONATA DEVICE, LATER IT WAS REPORTED THAT THE PATIENT EXPERIENCED URINARY RETENTION ISSUES AND COMPLICATIONS. PATIENT REPORTED ENDED UP WITH A ¨LEG BAG¨ FOR 7 DAYS POST-PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAD RECEIVED A PREVIOUS ACESSA PROCEDURE ON A LOWER SEGMENT FIBROID.

  Patient problems: Urinary Retention

  MAUDE report 23009901 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A FEMALE PATIENT, UNKNOWN AGE WAS TREATED WITH A SONATA DEVICE, LATER THE PATIENT WAS RE-ADMITTED FOUR DAYS AFTER THE PROCEDURE SHOWED PROFUSE BLEEDING. PATIENT RECEIVED A TRANSFUSION AND A FIBROID FROM THE LOWER SEGMENT WAS OBSERVED TO BE PROTRUDING. AT THE TIME OF THE EVENT PATIENT WAS BEING MONITORED TO SEE IF THE FIBROID WOULD BE DELIVERED ON ITS OWN, OTHERWISE THEY WERE GOING TO TAKE THE PATIENT BACK TO THE OPERATING ROOM TO REMOVE IT. IT WAS REPORTED THAT THE PATIENT HAD RECEIVED A PREVIOUS ACESSA PROCEDURE FOR A LOWER SEGMENT FIBROID.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Intermenstrual Bleeding

  MAUDE report 23009845 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025, DURING AN ACESSA PROCEDURE THAT THE PHYSICIAN PERFORMED THREE ABLATIONS ON A FIBROID. AFTER THE THIRD ABLATION, IT WAS OBSERVED THAT THERE WAS A HEAT TRANSFER FROM THE SEROSA TO THE TISSUE NEAR THE BLADDER. THE UROLOGIST INTERVENED BY FILLING THE BLADDER AND PLACING A CATHETER. PROCEDURE WAS COMPLETED. THE PATIENT REQUIRED UROLOGY CONSULTATION, OBSERVATION ADMISSION FOR TWO DAYS FOR PAIN AND FOLEY CATHETER FOR 7 DAYS AND A CT UROGRAM PLANNED WITHIN ONE WEEK. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Burn(s); Pain

  MAUDE report 22984071 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 A PATIENT RECEIVED AN ACESSA PROCEDURE WHICH WAS REPORTED AS UNEVENTFUL. A WEEK LATER THE PATIENT WAS ADMITTED TO A DIFFERENT HOSPITAL DUE TO PELVIC PAIN AND RESULTED IN A COMPLETE HYSTERECTOMY. THE REASON FOR THE HYSTERECTOMY WAS REPORTED AS THE PATIENT PRESENTED WITH A PELVIC ABSCESS AND THE PATIENT DID NOT HAD FUNDUS AND MISSING POSTERIOR WALL WITH A DIRECT COMMUNICATION TO THE ABDOMEN. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Bacterial Infection; Pelvic Pain

  MAUDE report 22805633 ↗
• InjuryAug 7, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING AN ACESSA PROCEDURE ON (B)(6) 2025, THE PROCEDURE WENT WELL AND AS THE PHYSICIAN WAS FINISHING AND WAS EXITING LAPAROSCOPICALLY, UPON REMOVING THE DEVICE FROM THE PATIENT, THE HANDPIECE WAS STILL HOT AND SLIPPED FROM THE PHYSICIAN´S HAND AND DAMAGED A SMALL PART OF THE SIGMOID COLON. AN INJURY WAS REPORTED AT THIS POINT. A GASTRO INTERNAL SPECIALIST WAS BROUGHT IN TO EVALUATE THE PATIENT. NO INFORMATION WAS PROVIDED AT THIS POINT ON WHAT INTERVENTION WAS PROVIDED.

  Patient problems: Bowel Perforation

  MAUDE report 22738075 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED AN ACESSA PROCEDURE ON (B)(6) 2025, THE PHYSICIAN REPORTED THAT AFTER THE ABLATIONS THEY OBSERVED A POSSIBLE SCARRING ABOVE THE UTERUS AT THE END OF THE PROCEDURE. NO ADDITIONAL INTERVENTION WAS REPORTED AND THE PATIENT HAD A SMALL UTERUS. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 22717598 ↗
• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A COMBINATION OF PROCEDURES ON (B)(6) 2025 WHICH INVOLVED A MYOSURE REACH PROCEDURE USING AN OMNI HYSTEROSCOPE AND, AN ACESSA PROCEDURE. PROCEDURES WERE REPORTED AS HAVING BEEN COMPLETED SUCCESSFULLY. THE PHYSICIAN LATER REPORTED THAT THE ACESSA PROCEDURE WAS UNREMARKABLE AND THAT THE PROCEDURE INCLUDED TREATMENT OF THREE FIBROIDS RANGING FROM 1 TO 3 CM. THE PATIENT CAME BACK ON (B)(6) WITH SEVERE PELVIC PAIN, ELEVATED WHITE BLOOD CELL COUNT. A CT SCAN DID NOT SHOW ANY PERFORATION. PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION AND DEVELOPED AIR IN THE ABDOMINAL CAVITY. A SURGERY WAS PERFORMED AND A 5 MM PERFORATION WAS OBSERVED ON THE SMALL BOWEL WITH SUBSEQUENT RESECTION. PATIENT WAS REPORTED AS OBESE AND NEEDED RETRACTION TO KEEP THE BOWEL OUT OF THE WAY DURING THE PROCEDURE. TREATING PHYSICIAN´S ASSUMPTION NOTED THAT THE HANDPIECE MIGHT HAVE TOUCHED THE BOWEL AFTER THE USE WHILE IT WAS STILL HOT AND THIS CAUSED A THERMAL INJURY THAT RESULTED IN A PERFORATION 12 DAYS AFTER THE SURGERY. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Bacterial Infection; Bowel Burn; Bowel Perforation

  MAUDE report 22701272 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED AN ACESSA PROCEDURE ON (B)(6) 2025. IT WAS OBSERVED THAT THE PATIENT HAD LOW HEMOGLOBIN LEVELS AND REQUIRED A BLOOD TRANSFUSION PRIOR TO THE PROCEDURE. ADDITIONAL TRANSFUSIONS WERE GIVEN DURING THE PROCEDURE. DURING THE PROCEDURE TWO UTERINE SEROSAL PUNCTURE SITES FROM THE ACESSA HANDPIECE REQUIRED MORE THAN NORMAL INTERVENTIONS TO CONTROL AND GAIN HEMOSTASIS. SURGEONS USED SEVERAL HEMOSTATIC AGENTS LIKE SURGICEL AND HEMOSTATIC FOAM TO GAIN HEMOSTASIS AS WELL AS THE COAGULATION FEATURE FROM ACESSA AND A SURGICAL BOVIE. DUE TO THE PATIENT LOSING BLOOD DURING THE PROCEDURE THE ANESTHESIA TEAM RECOMMENDED TO GIVE THE PATIENT TWO ADDITIONAL BLOOD UNITS IN THE OPERATING ROOM. PATIENT WAS ADMITTED FOR ADDITIONAL OBSERVATION AND ONE ADDITIONAL UNIT OF BLOOD WAS GIVEN POST PROCEDURE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ¨ANASARCA¨ AND THAT ON DAY 5 A CT SCAN WAS NEGATIVE. ON DAY 6 PHYSICIAN HAD CONCERN OF A COMPARTMENT SYNDROME DUE TO THE REDDENING OF THE ABDOMEN AND THE PATIENT WAS TRANSFERRED TO ANOTHER TREATMENT FACILITY FOR FURTHER STUDIES. A COMPARTMENT SYNDROME WAS RULED OUT AT THIS POINT. PATIENT WAS SEEN BY MULTIPLE SPECIALISTS AND NO

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22636764 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HOLOGIC RECEIVED INFORMATION FROM ONE ARTICLE CALLED PREGNANCY OUTCOMES AFTER LAPAROSCOPIC RADIOFREQUENCY ABLATION OF UTERINE LEIOMYOMAS COMPARED WITH MYOMECTOMY IN WHICH ONE PARTICIPANT EXPERIENCED UTERINE RUPTURE 10 WEEKS AFTER LAPAROSCOPIC RADIOFREQUENCY ABLATION DURING TREATMENT WITH VAGINAL MISOPROSTOL TO MANAGE EARLY PREGNANCY LOSS. THE PARTICIPANT WAS 31 YEARS OLD, G4P0A3 AND HAD FOUR LEIOMYOMAS, RANGING FROM 4 TO 6 CM IN SIZE, THAT WERE ABLATED. THE PATIENT WAS FOUND TO BE PREGNANT 2 WEEKS AFTER THE PROCEDURE. SIX WEEKS LATER, THE PARTICIPANT PRESENTED WITH AN ANEMBRYONIC PREGNANCY. THE PATIENT ELECTED FOR MEDICATION MANAGEMENT 9 AND 6/7 WEEKS AFTER RADIOFREQUENCY ABLATION AND WAS PRESCRIBED 800 MG VAGINAL MISOPROSTOL. TWELVE HOURS LATER, SHE PRESENTED TO THE EMERGENCY DEPARTMENT FOR SEVERE ABDOMINAL PAIN AND WAS FOUND TO HAVE FREE FLUID IN THE ABDOMEN. SHE SUBSEQUENTLY UNDERWENT AN EXPLORATORY LAPAROTOMY WHICH REVEALED 800 ML HEMOPERITONEUM AND A POSTERIOR UTERINE RUPTURE WITH PRODUCTS OF CONCEPTION EXTRUDING FROM THE DEFECT WITH A NECROTIC LEIOMYOMA ADJACENT TO THE RUPTURE, CONFIRMED BY SUBSEQUENT PATHOLOGIC EXAMINATION. THIS PARTICIPANT EXPERIENCED ANOTHER MISCARRIAGE IN

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hematoma; Induced Abortion

  MAUDE report 22510227 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED PREVIOUSLY AN ACESSA PROCEDURE ON (B)(6) 2023. LATER THE PATIENT WAS REPORTED TO HAVE BEEN PREGNANT 14 MONTHS AFTER THE ACESSA PROCEDURE (AROUND (B)(6) 2024), ADDITIONALLY THE PATIENT RECEIVED A ROBOTIC MYOMECTOMY ON (B)(6) 2024. IT WAS LATER REPORTED THAT THE PATIENT SUFFERED A UTERINE RUPTURE AT 28 WEEKS AND THE BABY DID NOT SURVIVE. THE PATIENT WAS DOING WELL. THE FIBROIDS TREATED DURING THE ACESSA PROCEDURE WERE A 2CM INTRAMURAL FIBROID AND A 5 CM SUBSEROSAL. NO ISSUES WERE REPORTED DURING THE ACESSA PROCEDURE AND RELATED TO THE UTERINE RUPTURE THE PATIENT DID NOT REQUIRE A HYSTERECTOMY. THE PATIENT WAS REPORTED AS BEING STABLE AND IMPROVING.

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

  MAUDE report 22496181 ↗
• InjuryJul 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED AN ACESSA PROCEDURE ON (B)(6) 2020 AND A BOWEL PERFORATION WAS REPORTED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Bowel Perforation

  MAUDE report 22403703 ↗
• InjuryJul 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED AN ACESSA PROCEDURE ON (B)(6) 2025, LATER THE PATIENT WAS REPORTED TO HAVE RETURNED TO THE PHYSICIAN IN (B)(6) 2025 WITH ABDOMINAL PAIN AND BLEEDING. PATIENT WAS DIAGNOSED WITH FIBROID NECROSIS AND SEPSIS AND RECEIVED AN UNPLANNED HYSTERECTOMY. ADDITIONAL INFORMATION WAS RECEIVED PHYSICIAN REPORTED THAT HE BELIEVED THAT THE ISSUE WAS NOT DIRECTLY RELATED TO THE ACESSA BUT A COMBINED PROCEDURE WITH MYOSURE. THE REPORT FROM THE HOSPITAL MENTIONED THAT THE PATIENT HAD A DEGENERATING CENTRAL MASS WHICH DID NOT SOUND LIKE THE SUBSEROSAL 10 CM MYOMA TREATED WITH THE ACESSA BUT AN INCOMPLETELY RESECTED SUBMUCOUS MYOMA. THE PHYSICIAN STATED THAT HE BELIEVED THAT THE COMBINATION WITH A BOGGY SOFT POST ACESSA UTERUS, THIS COULD HAVE LED TO THE ASCENDING INFECTION THAT PRESENTED AS AN ENDOMYOMETRITIS. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Abdominal Pain; Bacterial Infection; Intermenstrual Bleeding; Sepsis

  MAUDE report 22403673 ↗