Acessa ProVu System 7100 (UDI 00854763006232)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00854763006232), received between Oct 19, 2020 and Feb 26, 2026 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Accessory Incompatible” (1 report).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 24461967 ↗
• MalfunctionJul 15, 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 REPORTED THAT THE SYSTEM SHOWED AN ERROR ON THE SCREEN AS INSTRUMENT FAILURE. THE UNIT WAS RESET AND UNPLUGGED BUT THIS COULD NOT RESOLVE THE ISSUE. PROCEDURE WAS ABORTED AT THIS POINT. TROCARS HAD BEEN ALREADY PLACED ON THE PATIENT. THE CONSOLE WAS RETURNED FOR INVESTIGATION AND TO TEST FOR THIS FAILURE, THE CONSOLE WAS POWERED ON AND ALL ACCESSORIES WERE CONNECTED TO PERFORM THE ABLATION AND COAGULATION TESTS. THE CONSOLE WAS POWERED ON AND THE FUNCTIONAL TESTS WERE PERFORMED THREE SEPARATE TIMES TO CHECK FOR INTERMITTENCE. HERE, IT WAS OBSERVED THAT THE CONSOLE FUNCTIONED AS INTENDED DURING THE ABLATION AND COAGULATION TESTS AFTER EACH POWER CYCLE. HENCE, THE FAILURE MODE REPORTED BY THE CUSTOMER WAS NOT REPLICATED DURING INVESTIGATION. AN EXTERNAL VISUAL INSPECTION WAS CONDUCTED AND THERE WERE NO SIGNS OF DAMAGES OR MISUSE PRESENT ON THE CONSOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509918 ↗
• MalfunctionJul 9, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT DURING AN ACESSA PROCEDURE ON (B)(6) 2025, THE PHYSICIAN REPORTED THAT HALF-WAY THROUGH THE PROCEDURE, AN ERROR WAS OBSERVED IN THE CONSOLE. CUSTOMER POWERED DOWN THE CONSOLE AND RESTARTED IT BUT ISSUE DID NOT CLEAR, PADS AND CABLES WERE REPLACED BUT THAT DID NOT FIX THE ISSUE. THE PROCEDURE AT THIS POINT WAS ABORTED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459850 ↗
• MalfunctionNov 13, 2024Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING AN ACESSA PROCEDURE ON (B)(6) 2024, AFTER COMPLETING THE INITIAL ASSESSMENT THE PROVU FREEZED UP. THE UNIT COULD NOT BE BOOTED BACK UP. MULTIPLE TROUBLESHOOTING MEASURES WERE ATTEMPTED, AND THEY COULD NOT RESTART THE MACHINE. THE PROCEDURE HAD TO BE ABORTED WITHOUT COMPLETION, THE TROCARS HAD ALREADY BEEN PLACED IN THE PATIENT. THE PATIENT WAS ON THE TABLE AND THE TREATMENT STARTED. NO MEDICAL INTERVENTION WAS REQUIRED AT THE MOMENT AND NO INJURIES REPORTED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678637 ↗
• 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 16924167 ↗
• MalfunctionNov 17, 2022Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT ON (B)(6) 2022, AN ACESSA PROCEDURE WAS PERFORMED, ONCE THE PHYSICIAN WAS IN THE ROOM THEY IDENTIFIED THAT THE CONSOLE DIDN'T RECOGNIZE THE LEG PADS. THE PHYSICIAN TRIED ALL TROUBLESHOOTING BUT COULD NOT GET THE SYSTEM TO FUNCTION AND THE CASE WAS ABORTED AND RESCHECHULED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15821371 ↗
• InjurySep 9, 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 AUGUST 9TH, BEFORE THE PROCEDURE THERE WAS A POWER SURGE AT THE FACILITY WHICH CAUSED THE CONSOLE TO POWER OFF. WHEN THE POWER CAME BACK ON THE CONSOLE WAS ATTEMPTED TO BE USED AND COULD NOT PERFORM ABLATION OR COAGULATION. THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE. THE PATIENT HAD ALREADY BEEN PLACED UNDER ANESTHESIA AND WITH THE TROCARS ON. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15392058 ↗
• InjuryOct 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACESSA PHYSICIAN NOTIFIED ACESSA REPRESENTATIVE THAT A PATIENT WHO HAD UNDERWENT THE ACESSA PROCEDURE ON (B)(6) 2020 HAD BEEN ADMITTED TO THE ICU POST-OPERATIVELY ON (B)(6) 2020. REPORTEDLY, THE PATIENT HAD COMPLAINED OF SEVERE PAIN BEFORE SHE WAS DISCHARGED FROM HER ACESSA PROCEDURE AND HAD ALSO CALLED THE ACESSA PHYSICIAN OVER THE FOLLOWING WEEKEND COMPLAINING OF PAIN. ON POST-OP DAY 4, WITH THE PATIENT ALSO COMPLAINING OF BLOATING, THE ACESSA PHYSICIAN SENT THE PATIENT IN TO BE EVALUATED. AS REPORTED BY THE ACESSA PHYSICIAN, THE PATIENT UNDERWENT BOWEL SURGERY TO REPAIR HER BOWEL FROM SUSPECTED BURN DAMAGE. THE PATIENT IS CURRENTLY ON ANTIBIOTICS AND IS RECOVERING SLOWLY.

  Patient problems: Bowel Burn

  MAUDE report 10702352 ↗