MAUDE Adverse Event Report: MINERVA SURGICAL, INC MINERVA SINGLE STERILE DISPOSABLE HANDPIECE; ENDOMETRIAL ABLATION DEVICE

Catalog Number	MIN9770
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670)
Health Effect - Clinical Codes	Bowel Burn (1756); Uterine Perforation (2121); Bowel Perforation (2668)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a minerva procedure was performed in a 35-year-old patient without prior gynecologic surgeries.Uterine sounding was performed first, and the doctor suspected a uterine perforation.Hysteroscopy was performed; however, the doctor was unable to visualize a perforation.The initial sounding length was measured at 7-cm, but after the suspected perforation, it read 9-cm.This value was used to calculate the length setting for the minerva device.Dilation of the cervical canal was performed; the exact degree of dilation unknown, then the minerva device was inserted and deployed.Exact degree of device deployment is unknown.The cervical balloon was inflated with 3cc of air, and uit was initiated but failed.The doctor suspected a cervical leak and added an additional 3cc of air.Uit was initiated for the second time and failed.There were no bubbles or hissing sounds observed at the time of the first or second uit.The doctor added another 3cc of air, and uit was initiated a third time and passed, which was followed with 120 seconds of uninterrupted therapy cycle.Upon completion, the balloon was deflated, device unlocked, closed, and removed.Post-ablation hysteroscopy was not performed.After endometrial ablation, the doctor performed a pre-scheduled laparoscopy and observed uterine perforation with evidence of thermal effect on the uterine serosa.Patient evaluation with the general surgeon for potential damage to the organs of the viscera identified four areas of unintended thermal effect on the small intestine.Bowel resection and reanastomosis were performed in all affected areas.The patient remained in the hospital for a few days, recovered, and was discharged.
Additional Manufacturer Narrative
The disposable handpiece used in this case was not returned, and therefore, a failure analysis of the complaint device could not be performed.No relevant information was identified during the lot history review that could have contributed to the reported event.Based on the information reviewed, there is no indication of a product deficiency directly related to the reported adverse event.The potential root cause of this complication was a result of sounding, dilation, or handpiece insertion.Although the uterine integrity test (uit) failed twice indicating a potential perforation, the user failed to abort the procedure in compliance with the minerva ifu.Perforations and injuries, such as thermal injury, are known complications of an endometrial ablation procedure.Complications associated with perforations and thermal injury are addressed in the warning and caution sections of the operator's manual and instructions for use, including the statements: use caution not to perforate the uterine wall when sounding, dilating, or inserting the disposable handpiece.If the minerva disposable handpiece is difficult to insert into the cervical canal, use clinical judgment to determine whether or not further dilation is required.Forcibly advancing the minerva disposable handpiece against resistance is likely to increase the risk of perforation or creation of a false passage.Sufficient dilation is required for safe insertion.Activation of the minerva disposable handpiece in the setting of uterine perforation is likely to result in serious patient injury.Excessive force applied during placement of the disposable handpiece may result in tissue injury, including perforation.If the uterine integrity test fails after reasonable attempts to implement the troubleshooting procedures, abort the procedure.Although designed to detect a perforation of the uterine wall, this test is an indicator only, and it might not detect all perforations.Clinical judgment must always be used.If a uterine perforation is suspected and/or confirmed, the procedure should be terminated immediately.Post-treatment, any patient-reporting signs/symptoms that could indicate a serious complication, e.G., bowel injury, should be thoroughly evaluated without delay.As with all endometrial ablation procedures, serious injury or death can occur, including but not limited to infection and injury to adjacent tissue, such as bowel, bladder, vagina, vulva, and/or perineum.

• Brand Name: MINERVA SINGLE STERILE DISPOSABLE HANDPIECE
• Common Device Name: ENDOMETRIAL ABLATION DEVICE
• Manufacturer (Section D): MINERVA SURGICAL, INC; 4255 burton dr.; santa clara 95054
• Manufacturer (Section G): MINERVA SURGICAL, INC.; 4255 burton drive; santa clara CA 95054
• Manufacturer Contact: angela gonzalez ; 4255 burton drive; santa clara, CA 95054 ; 6502843500
• MDR Report Key: 23577356
• Report Number: 3011011193-2025-00016
• Device Sequence Number: 13137877
• Product Code: MNB
• UDI-Device Identifier: 00862393000162
• UDI-Public: (01)00862393000162
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P140013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: MIN9770
• Device Lot Number: 25E09-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 35 YR
• Patient Sex: Female