Minerva RF Controller MIN180SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00862393000100), received between Jul 21, 2022 and Jan 25, 2023 — classified as 1 death, 2 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT USER PERFORMED AN ENDOMETRIAL ABLATION PROCEDURE ON A PATIENT SUFFERING FROM AUB(E). THE PROCEDURE WAS PERFORMED UNDER VERY LIGHT SEDATION. WITH 10 SECONDS REMAINING OF THE ABLATION CYCLE, THE PATIENT EXPERIENCED A VASOVAGAL REACTION AND BECAME UNRESPONSIVE. PATIENT WAS TAKEN TO THE ER DEPARTMENT, KEPT FOR OBSERVATION FOR 12 HOURS, FULLY RECOVERED AND DISCHARGED.

  Patient problems: Loss of consciousness

  MAUDE report 16244937 ↗
• InjuryJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MANUFACTURER PERIODICALLY REVIEWS THE MAUDE DATABASE FOR POTENTIAL COMPLAINTS AND ADVERSE EVENTS RELATED TO ITS COMMERCIALIZED MEDICAL DEVICES. DURING ONE OF THESE MAUDE DATABASE REVIEWS, MAUDE REPORT # (B)(4) WAS IDENTIFIED AS A POTENTIAL REPORTABLE EVENT. THIS REPORT IS FILED USING THE MANDATORY MEDWATCH REPORTING PROGRAM AND THEREFORE THE SAME EVENT (DESCRIBED IN THIS REPORT) WILL APPEAR TWICE ON THE MAUDE DATABASE. AS ORIGINALLY REPORTED IN THE MAUDE REPORT, "SURGEON REPORTED APPROXIMATELY 1 WEEK AFTER SURGERY THAT PATIENT SUSTAINED A THERMAL INJURY TO HER RECTOSIGMOID JUNCTION DURING AN ENDOMETRIAL ABLATION. THIS RESULTED IN A LOW ANTERIOR RESECTION WITH PROCTOCOLO ANASTOMOSIS. SURGEON REPORTS THAT BEFORE THE ENERGY WAS DELIVERED DURING THE ABLATION, THE MINERVA DEVICE PASSED BOTH PRE-TESTS AS IT TRIES TO DETECT ANY DEFECTS IN THE UTERUS. AFTERWARD IT IS HIS NORMAL PROCEDURE TO VISUALIZE THE ABLATED AREA WITH THE CAMERA, AND IN DOING SO, HE DISCOVERED THE MINERVA DEVICE PENETRATED THROUGH THE PATIENT'S UTERUS AND LIKELY BURNED THE PATIENT'S COLON WITH DELIVERY. PHYSICIAN IS UNSURE IF THIS ISSUE WAS A RESULT OF A DEVICE FAILURE." MINERVA SURGICAL MADE MULTIPLE ATTEMPTS TO OBTAI

  Patient problems: Bowel Burn; Uterine Perforation

  MAUDE report 15126672 ↗
• DeathJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MANUFACTURER RECEIVED MEDWATCH REPORT, (B)(4), ON JUNE 22ND, 2022, FROM FDA FOR SAME EVENT. THIS REPORT IS FILED USING THE MANDATORY MEDWATCH REPORTING PROGRAM AND THEREFORE THE SAME EVENT (DESCRIBED IN THIS REPORT) WILL APPEAR TWICE ON THE MAUDE DATABASE. THE ORIGINAL FACILITY REPORTED EVENT DESCRIPTION OF MEDWATCH STATED, "THE CO2 AND UTERINE CAVITY CHECKS WERE PERFORMED TWICE WITHOUT ANY ALERT TO PERFORATION AND INDICATED THE CAVITY WAS INTACT. NEVER ANY SIGNAL FROM THE DEVICE OR ALERTS THAT THERE COULD HAVE BEEN A PROBLEM". NO REPORT OF EVENT WAS RECEIVED BY MANUFACTURER FROM THE USER FACILITY. THIS REPORT REFLECTS THE RESULTS OF MANUFACTURER INVESTIGATION FOR THE EVENT PREVIOUSLY REPORTED BY THE FACILITY. MANUFACTURER HAS MADE AND DOCUMENTED MULTIPLE ATTEMPTS TO COMMUNICATE WITH THE FACILITY BY PHONE AND IN WRITING. MULTIPLE REQUESTS FOR PATIENT CHART, NAME OF MEDICAL PROVIDER, OTHER WERE REFUSED WITH INTERNAL POLICIES BEING CITED AS THE REASON FOR REFUSAL. FACILITY WAS INFORMED IN WRITING THAT ACCORDING TO 45 CFR 164.512(B)(1)(III) THE HEALTH AND ACCOUNTABILITY ACT OF 1996 ("HIPPA") INCLUDES A SPECIFIC EXCEPTION WHICH ALLOWS A "COVERED ENTITY" (E.G., PHYSICIAN, HOSPITAL) TO D

  Patient problems: Bowel Perforation; Peritonitis; Uterine Perforation

  MAUDE report 15077668 ↗