Acessa ProVu System 7700Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15420045515291), received between Feb 26, 2026 and May 13, 2026 — classified as 3 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 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: Bladder Dysfunction; Burn(s); Pain

  MAUDE report 25165259 ↗
• 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 TABLE TOP 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 24461928 ↗
• 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 24461915 ↗