Acessa ProVu System 7100 (UDI 15420045515307)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15420045515307), received between Dec 14, 2023 and Jan 6, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (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. 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.

• MalfunctionJan 6, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ACESSA PROCEDURE ON (B)(6) 2025, THERE A TABLETOP GENERATOR INDICATOR (TTFG) THAT WOULD NOT STAY ON AFTER THE TTFG WAS PLUGGED INTO THE SYSTEM. THE STAFF CHECKED THE TTFG CABLE AND THE TTFG PLACEMENT AND CONFIRMED BOTH WERE CORRECT. THE SYSTEM POWER CYCLED AND AN ERROR WAS RECEIEVED WHEN IT POWERED BACK ON THAT STATED GUIDANCE FAILURE, NO TRACKER AND THERE WAS NO GREEN CHECK ON SCREEN TO INDICATE THE TTFG WAS CONNECTED. THE SYSTEM POWER CYCLED MULTIPLE TIMES AND THE TTFG CABLE WAS UNPLUGGED AND RE-PLUGGED FROM BOTH THE SYSTEM AND THE TTFG WHICH DID NOT RESOLVE. THE PHYSICIAN CHOSE TO ABORT THE PROCEDURE WHERE NO 3D GUIDANCE COULD BE USED. AFTER TESTING THE SYSTEM ON SITE WITH ADDITIONAL EQUIPMENT, IT WAS DISCOVERED THAT THE ISSUE WAS WITH THE GENERATOR. THE TESTING SUCCESSFULLY CONNECTED THE TTFG TO THE UUI SYSTEM WITH THE SAME TTFG CABLE WITH NO ERRORS AND CONNECTION ISSUES. THE SYSTEM WORKED AS INTENDED AFTER SWITCHING THE CONSOLE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977054 ↗
• MalfunctionDec 29, 2025Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT DURING AN ACESSA PROCEDURE ON (B)(6) 2025, THE PHYSICIAN REPORTED THAT AFTER 30 SECONDS INTO THE SYSTEM BEING POWERED ON, AN ERROR WAS SHOWN RELATED TO INSTRUMENT FAILURE. SYSTEM WAS POWERED CYCLED BUT THE PROCEDURE WAS ABORTED. AN INCISION WAS REPORTED AND THE HANDPIECE WAS INSIDE THE PATIENT WHEN THE ISSUE HAPPENED. NO MEDICAL INTERVENTION WAS REPORTED AND NO PATIENT INJURY REPORTED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907574 ↗
• InjuryDec 14, 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)(4), 2023. THE PHYSICIAN EXPERIENCED ISSUES WITH THE FOOT PEDAL AND COULD NOT ACTIVATE THE ABLATION. DUE TO THE ISSUES EXPERIENCED WITH THE CONSOLE THE PROCEDURE HAD TO BE ABORTED, THE TROCARS HAD ALREADY BEEN PLACED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325871 ↗