Acessa ProVu Handpiece 7300Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00854763006140), received between Jun 4, 2019 and May 12, 2026 — classified as 15 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ACESSA PROCEDURE ON (B)(6) 2026, THE PHYSICIAN TREATED 5 FIBROIDS. UPON TREATING THE 5TH OF THE FIBROIDS , A BURN TO THE ABDOMINAL WALL WAS NOTICED. PATIENT WAS SENT HOME AFTER THE PROCEDURE. PHYSICIAN BELIEVED THAT THE ULTRASOUND PROBE MAY BE THE ISSUE AS THE PROBLEM OCCURED AT THE LOCATION. ON A FOLLOW UP WITH THE PHYSICIAN SHE REPORTED THAT THERE WERE NO ADDITIONAL PROCEDURES OR INTERVENTIONS DONE TO THE PATIENT AND THE PATIENT DIDN´T REQUIRE ADMISSION. THE AREA OF THE THERMAL SPREAD WAS AGAINST THE ANTERIOR WALL AND AWAY FROM THE BLADDER. PHYSICIAN BELIEVED THAT THE PATIENT WILL NOT EXPERIENCE ANY LONG TERM SYMPTOMS FROM THIS. THE INJURY WAS REPORTED AS A CIRCULAR SHAPE AND HAS BEEN WITHIN THE TRAJECTORY OF THE ULTRASOUND PROBE AS SHE WAS INSERTING THE ACESSA HANDPIECE FROM THE PATIENT LEFT TOWARDS THE RIGHT AND THAT IS WERE SHE OBSERVED THE MARK. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 25149472 ↗
• MalfunctionAug 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ACESSA PROCEDURE ON (B)(6) 2025, THE PHYSICIAN REPORTED THAT DURING THE PROCEDURE THEY WERE TRYING TO ABLATE A CALCIFIED FIBROID AND WHEN THEY WERE PULLING FROM THE FIBROID THE TIP DISCONNECTED FROM THE SHAFT OF THE HANDPIECE. THE TIP REMAINED IN THE FIBROID. PHYSICIAN WAS ABLE TO RETRIEVE IT WITH A GRASPER AND REMOVE IT FROM THE PATIENT. ADDITIONAL DESCRIPTION OF THE FIBROIDS WAS PROVIDED, THE FIRST FIBROID WAS INTRAMURAL 3CM ON THE LEFT FUNDAL SIDE, THE SECOND WAS AN EXTREMELY CALCIFIED FIBROID IN THE POSTERIOR LOWER UTERINE SEGMENT ON THE LEFT SIDE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SECOND DEVICE. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22841670 ↗
• InjuryJun 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ACESSA PROCEDURE ON (B)(6)2025, THE PHYSICIAN REPORTED THAT WHEN HE ATTEMPTED TO RETRACT THE HANDPIECE FROM THE PATIENT´S FIBROID, ONE OF THE NEEDLES STAYED INSIDE THE FIBROID AND WAS STICKING OUT OF THE TOP OF THE FIBROID. ONCE THE PHYSICIAN REMOVED THE WHOLE HANDPIECE FROM THE PATIENT, HE REMOVED THE STUCK NEEDLE AND NOTICE THAT THE TIP OF THE DEVICE WAS MISSING. AFTER TAKING A CLOSER LOOK AT THE FIBROID INSIDE THE PATIENT THE TIP WAS SEEN WEDGED INSIDE THE TOP OF THE FIBROID. THE PHYSICIAN WAS ABLE TO REMOVE THE ENTIRELY OF THE TIP THAT WAS WEDGED ON TOP OF THE FIBROID AND NO HARM WAS REPORTED TO THE PATIENT. NO ADDITIONAL INTERVENTION WAS REQUIRED AND THE PROCEDURE WAS COMPLETED USING A SECOND DEVICE. THE PIECES WERE SET ASIDE AND PREPARED TO BE RETURNED TO THE MANUFACTURER. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22309253 ↗
• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT REPORTED THAT SHE RECEIVED AN ACESSA PROCEDURE ON AN UNKNOWN DATE, AND THAT THE BECAME PREGNANT SOME TIME AFTER THE PROCEDURE, AND THAT SHE EXPERIENCED A UTERINE RUPTURE AT 12 WEEKS OF PREGNANCY. THE PHYSICIAN SEWED THE RUPTURE AT 12 WEEKS WHICH WAS SUCCESSFUL. PATIENT IS CURRENTLY 25 WEEKS PREGNANT AND REPORTED HEALTHY WITHOUT COMPLICATIONS. NO ISSUES REPORTED ON THE ORIGINAL ACESSA PROCEDURE AND NO LOT NUMBER AVAILABLE. DATE OF PROCEDURE WAS UNKNOWN BUT 6 MONTHS FROM REPORTED DATE. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Rupture; Uterine Perforation

  MAUDE report 22169486 ↗
• MalfunctionMay 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACESSA PROCEDURE ON (B)(6) 2025, THE CUSTOMER REPORTED THAT AFTER THE 6TH ABLATION AND WHILE THE DEVICE WAS STILL IN THE PATIENT THE PHYSICIAN COULD NOT DEPLOY THE NEEDLES OF THE HANDPIECE AS THE SLIDER KNOW WAS STUCK AND COULD NOT DEPLOY. THE DEVICE WAS REMOVED FROM THE PATIENT AND A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. WHEN THE DEVICE WAS RETURNED FOR INVESTIGATION IT WAS OBSERVED THAT IN 2 NEEDLES THE TIP WAS MISSING AND BROKEN, THE OTHER 5 WERE BENT. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061354 ↗
• InjuryMar 6, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING AN ACESSA PROCEDURE ON (B)(6) 2024, THE PHYSICIAN WAS ABLATING A FIBROID NEAR THE INTERIOR ABDOMINAL WALL, THE SALINE BALLOON MANIPULATOR WAS ACCIDENTALLY DEFLATED BY THE TECH AND THE UTERUS WAS MANIPULATED TO THE INTERIOR ABDOMINAL WALL AND A SMALL BURN TO THE ABDOMINAL WALL HAPPENED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DEVICE WAS DISCARDED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 21540114 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ACESSA PROCEDURE WAS PERFORMED ON (B)(6) 2025 WITH NO KNOWN ISSUES. ON (B)(6), 2025 THE PATIENT PRESENTED TO THE EMERGENCY ROOM AT (B)(6)I WITH ¿ASCITES AND FREE AIR.¿ THE PATIENT WAS TAKEN TO THE OPERATING ROOM WHERE THERE WAS FOUND TO BE A BOWEL INJURY AND 1.7 LITERS OF FECES IN THE STOMACH. A FOLLOW UP EMAIL WAS RESPONDED IN WHICH THE PHYSICIAN CONFIRMED THAT THE INJURY WAS THERMAL. THE PATIENT´S BOWELS WERE ADHERED TO THE UTERUS AND THE ADHESIONS WERE NOT TAKEN DOWN. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Ascites; Bowel Burn

  MAUDE report 21403367 ↗
• InjuryDec 30, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ACESSA PROCEDURE ON (B)(6) 2024 WHILE THE PHYSICIAN WAS PERFORMING THE PROCEDURE, HE ABLATED A FIBROID AND REALIZED THAT ONE OF THE NEEDLES DIDN´T SEEM FULLY SEATED. THE HANDPIECE WAS DEPLOYED OUTSIDE THE PATIENT AND NOTICED THAT TWO TIPS WERE SHORTER THAT THE REST OF THE OTHERS. ONE OF THE NEEDLE TIPS WAS FOUND STUCK TO THE SIDE OF THE ULTRASOUND PROBE, THE PHYSICIAN USED GRASPERS TO REMOVE IT. POST PROCEDURE THE PHYSICIAN THOUGHT THAT MAYBE THE OTHER TIP WAS INSIDE A FIBROID. PHYSICIAN REPORTED THAT NO ADDITIONAL MEDICAL INTERVENTION REQUIRED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21036172 ↗
• InjuryDec 6, 2024Adverse 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)96) 2024, THE COAGULATION FUNCTION WAS NOT BURNING CORRECTLY AND THE PUNCTURE SITE CONTINUED TO BLEED. THE BLEEDING WAS FROM THE FIBROID BEING TREATED AND THE AMOUNT OF BLOOD COULD NOT BE SPECIFIED. BLEEDING WAS STOPPED WITH A SEPARATE MONOPOLAR INSTRUMENT. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS DOING FINE. NO OTHER ADDITIONAL INTERVENTION WAS REQUIRED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20870099 ↗
• InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON APRIL 11, AN ACESSA PROCEDURE WAS PERFORMED AND, DURING THE PROCEDURE, THE DOCTOR WAS WATCHING THE SCREEN WHILE INSERTING THE HANDPIECE. THE DOCTOR WENT INTO THE BOWEL WHILE CAUSING A PERFORATION. A GENERAL SURGEON WAS CALLED INTO THE ROOM TO STITCH UP THE PATIENT. AFTER THE PERFORATION WAS STITCHED THEY WERE ABLE TO COMPLETE THE ACESSA PROCEDURE. THE PATIENT WAS DOING WELL WHEN SHE LEFT THE OPERATING ROOM. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Bowel Perforation

  MAUDE report 19202553 ↗
• MalfunctionJul 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ACESSA PROCEDURE ON (B)(6) 2023, THE PHYSICIAN REPORTED THAT THE NEEDLE DETACHED 5CM DEEP INTO THE FIBROID. WHEN REMOVING THE HANDPIECE THE WHITE RING FELL BUT IT WAS RETRIEVED BY THE PHYSICIAN. THEN THE PHYSICIAN SPENT HALF AN HOUR TRYING TO GET THE TIP OUT USING ULTRASOUND AND THE SAME PUNCTURE HOLE. HE COAGULATED AROUND THE AREA AND WAS ABLE TO RETRIEVE THE NEEDLE WITH GRASPERS. THE PHYSICIAN PROVIDED ADDITIONAL INFORMATION IN WHICH HE DESCRIBED THAT THE INCISION HAD TO BE WIDENED FOR THE RFA NEEDLE IN THE SKIN AND CONVERTED TO AN ADDITIONAL 5 MM TROCAR. ALL THE PIECES DETACHED FROM THE ACESSA WERE ABLE TO BE RETRIEVED. IMAGES ARE PENDING TO BE SHARED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17336729 ↗
• InjuryJun 30, 2023Adverse 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 AN UNKNOWN DATE AND THAT IT WENT UNEVENTFUL. BUT LATER THE PATIENT RETURNED TO THE PHYSICIAN WITH PELVIC INFLAMMATORY DISEASE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Pelvic Inflammatory Disease

  MAUDE report 17242987 ↗
• MalfunctionMay 12, 2023Adverse 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) 2023, THE PHYSICIAN REPORTED THAT EXPERIENCED ISSUES WITH THE EQUIPMENT NOT RECOGNIZING THE HANDPIECE, THE PHYSICIAN WAS ALREADY INSIDE THE UTERINE CAVITY AND WAS UNABLE TO GET THE HANDPIECE RECOGNIZED BY THE EQUIPMENT DURING THE PROCEDURE, THEY SWAPPED THE HANDPIECE WITH NO RESULTS. THE PROCEDURE WAS ABORTED, AND THE PATIENT RESCHEDULED. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924229 ↗
• MalfunctionMay 12, 2023Adverse 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) 2023, THE PHYSICIAN REPORTED THAT EXPERIENCED ISSUES WITH THE EQUIPMENT NOT RECOGNIZING THE HANDPIECE, THE PHYSICIAN WAS ALREADY INSIDE THE UTERINE CAVITY AND WAS UNABLE TO GET THE HANDPIECE RECOGNIZED BY THE EQUIPMENT DURING THE PROCEDURE, THEY SWAPPED THE HANDPIECE WITH NO RESULTS. THE PROCEDURE WAS ABORTED, AND THE PATIENT RESCHEDULED. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924206 ↗
• InjuryOct 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 AN ACESSA PROCEDURE WAS PERFORMED, WHEN THE PHYSICIAN WENT TO USE THE HANDPIECE, GOT RF SYS ERROR 8048, THE PHYSICIAN DID A HARD RESET AND THEN GOT A CJ CHECK ERROR, THEY POWERED OFF/ON, AND IT STILL DID NOT WORK. THEY USED A SECOND HANDPIECE AND WHEN THEY WENT TO USE IT, THEY NOTICED THAT THE CONSOLE TEMP WHICH SHOULD HAVE BEEN AT OR AROUND 37 AND WAS AT 0 CELSIUS SO IT WAS UNABLE TO BE USED. THE PROCEDURE HAD TO BE ABORTED AND RESCHEDULED. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND THE PHYSICIAN HAD ALREADY INSERTED TWO TROCARS AND THE DISPOSABLE HANDPIECE. NO INJURY TO THE PATIENT AND NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15556020 ↗
• InjuryOct 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON 2022 AN ACESSA PROCEDURE WAS PERFORMED, WHEN THE PHYSICIAN WENT TO USE THE HANDPIECE, GOT RF SYS ERROR 8048, THE PHYSICIAN DID A HARD RESET AND THEN GOT A CJ CHECK ERROR, THEY POWERED OFF/ON, AND IT STILL DID NOT WORK. THEY USED A SECOND HANDPIECE AND WHEN THEY WENT TO USE IT, THEY NOTICED THAT THE CONSOLE TEMP WHICH SHOULD HAVE BEEN AT OR AROUND 37 AND WAS AT 0 CELSIUS SO IT WAS UNABLE TO BE USED. THE PROCEDURE HAD TO BE ABORTED AND RESCHEDULED. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND THE PHYSICIAN HAD ALREADY INSERTED TWO TROCARS AND THE DISPOSABLE HANDPIECE. NO INJURY TO THE PATIENT AND NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15555362 ↗
• InjuryJul 15, 2022Adverse 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) 2022, IN WHICH THE PATIENT WAS A 36 YEAR FEMALE WITHOUT ANY HISTORY OF CARDIAC ISSUES AND OBESE, WHILE TREATING A FIBROID IMMEDIATELY AFTER THE PEDAL WAS DEPRESSED AND ENERGY WAS BEING DELIVERED THE PATIENT´S HEART RATE DROPPED DRASTICALLY TO 30 BMP AND THAT CHANGE LASTED FOR AT LEAST 30 S DURING THE TREATMENT. AFTER THE ABLATION ENDED THE HEART RATE RETURNED TO NORMAL. THE EVENT ONLY HAPPENED ONCE DURING THE PROCEDURE AND THE PATIENT HAD NO ADDITIONAL EPISODES, WAS AWAKENED AT THE END OF THE PROCEDURE, EXTUBATED AND SENT TO THE PACU. NO ADDITIONAL INFORMATION WAS GIVEN.

  Patient problems: Bradycardia

  MAUDE report 15034134 ↗
• InjuryJan 11, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING AN ACESSA PROCEDURE ON (B)(6), THE PHYSICIAN ACCIDENTALLY ABLATED THE PATIENT´S COLON FOR 30 SECONDS WHILE PERFORMING AN UTERINE ABLATION. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND A GENERAL SURGEON WAS CALLED TO ASSESS IF THE PATIENT WOULD REQUIRE A COLON RESECTION. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Bowel Burn

  MAUDE report 13233007 ↗
• InjuryJan 10, 2020Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, A PATIENT CALLED IN TO THE ACESSA PATIENT LINE COMPLAINING OF SYMPTOMS POST-ACESSA PROCEDURE, WHICH TOOK PLACE ON (B)(6) 2019. THE PATIENT COMPLAINED OF BLADDER PAIN AND URINARY RETENTION, AS WELL AS CONTINUED POST-OPERATIVE MENORRHAGIA.

  Patient problems: Pain

  MAUDE report 9576166 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem

  ACESSA HEALTH WAS NOTIFIED BY A PHYSICIAN ON 12/11/2019 THAT THEIR PATIENT WAS HAVING COMPLICATIONS POST-ACESSA PROCEDURE, WHICH WAS PERFORMED ON (B)(6) 2019. THE PHYSICIAN STATED THAT THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL 3 DAYS POST-OP TO TREAT A SUSPECTED INFECTION, IDENTIFIED BY AN ELEVATED WHITE BLOOD CELL (WBC) COUNT. AFTER SEVERAL ROUNDS OF ANTIBIOTICS WERE UNSUCCESSFUL AT STABILIZING THE PATIENT'S WBC COUNT, AND WITH THE PHYSICIAN FEARSOME OF SEPSIS, THE PHYSICIAN MADE THE DECISION TO PERFORM A HYSTERECTOMY, ON (B)(6) 2019, TO ELIMINATE THE SOURCE OF INFECTION. PATIENT IS REPORTED TO BE DOING WELL AFTER HER HYSTERECTOMY, HAVING BEEN DISCHARGED FROM THE HOSPITAL FOUR DAYS AFTER THE PROCEDURE WITH STABLE BLOOD COUNT.

  Patient problems: Bacterial Infection

  MAUDE report 9540889 ↗
• MalfunctionJun 4, 2019Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE THE DISTAL TIP DETACHED FROM SLOTTED TUBE, CAUSING THE DISTAL TIP AND INSULATING RING TO SEPARATE FROM THE REST OF THE HANDPIECE. THIS HAPPENED OUTSIDE OF THE PATIENT AND IT WAS CONFIRMED THAT NOTHING FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP HANDPIECE AND THERE WAS NO REPORT OF PATIENT HARM, INJURY, OR ADVERSE OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8666181 ↗