MAUDE Adverse Event Report: Minerva Surgical, Inc. Minerva Single Sterile Disposable Handpiece; Endometrial Ablation Device

Catalog Number	MIN9770
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	06/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the final seconds (around 110-112 seconds) of a minerva endometrial ablation procedure, a bubbling or gurgling sound was noted.Per the physician, the controller released gas, followed by hot fluid leaking from the cervix.This fluid caused a superficial, first-degree burn to an area of the vaginal mucosa adjacent to the cervix.
Additional Manufacturer Narrative
Per the physician's interview the treating physician indicated that she is highly experienced and had never encountered this issue before, noted that the initial device setup and seal were successful.The pre-procedure 3d ultrasound measurements matched intraoperative findings perfectly, and the patient was actively menstruating at the time.The minerva controller completed the treatment cycle normally without triggering any pressure alarms or error messages, and a post-procedure inspection confirmed that the device balloon appeared entirely normal.The physician confirmed there was no further patient treatment or follow-up required.The facility retained the products and has not returned them to axora medical for investigation despite multiple follow-up attempts to arrange product return.Based on the available information, there was no indication of a product malfunction since the handpiece performed as intended.There was no apparent malfunction that axora medical was aware of at this time.The minerva surgical ea system operator's manual states thermal injury is a known complication of an endometrial ablation procedure, in section 7.2 other adverse events, and is addressed in the warning and caution sections, including the statements: - confirm that the vaginal speculum is an adequate size (width and length) to assure full separation of vaginal and vulvar tissue away from the sheath of the device, to avoid inadvertent thermal injury, and to provide visibility of the cervix.- leave the vaginal speculum in place throughout the procedure.- during the ablation cycle, ensure the connection tubing is not kinked or twisted, which could reduce the flow of argon gas and reduce the effect of ablation.- if during the ablation cycle the cervical balloon does not adequately seal the cervical canal, unintended thermal damage to the endocervical canal may occur as a result of hot fluid leaking from the uterine cavity into the canal.Use clinical judgment to continue with the ablation procedure if such a leak is suspected.- as with all endometrial ablation procedures, serious injury or death can occur, including but not limited to thermal 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 drive; santa clara CA 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 ; +1(650)284-3500
• MDR Report Key: 50074376
• Report Number: 3011011193-2026-00009
• Device Sequence Number: 10264620
• Product Code: MNB
• UDI-Device Identifier: 00862393000162
• UDI-Public: 00862393000162
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2026

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: 116860340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2025
• 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: Other
• Patient Sex: Female