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

Catalog Number	MIN9770
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Uterine Perforation (2121)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the treating physician had difficulty with the dilation of the endocervical canal.The physician was reported to have dilated the patient to 7 and attempted to insert the minerva device into the uterine cavity.The tenaculum was reported to have slipped, which caused the minerva device to enter the cavity, resulting in a uterine perforation.The doctor confirmed the perforation via hysteroscopy and converted to hysterectomy.
Additional Manufacturer Narrative
Minerva surgical contacted the treating physician on (b)(6) 2025 to gather additional information.The treating physician noted hysterectomy was performed because the perforation site was bleeding.The disposable handpiece used in this case was not returned, and therefore, a failure analysis of the complaint device could not be performed.The lot number was not provided by the customer, so a device history review was not performed.Handpieces meet all qa specifications prior to being released, including adequate sterilization.Uterine perforations are known complications of an endometrial ablation procedure.Complications associated with perforations 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.- activation of the minerva disposable handpiece in the setting of a 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 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.- 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, PRODUCT CODE: MNB
• Manufacturer (Section D): MINERVA SURGICAL, INC; 4255 burton dr.; 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 ; 6502843500
• MDR Report Key: 23991492
• Report Number: 3011011193-2026-00001
• Device Sequence Number: 21460018
• Product Code: MNB
• UDI-Device Identifier: 00862393000162
• UDI-Public: (01)00862393000162
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 01/05/2026

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
• 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: 12/15/2025
• Initial Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Hospitalization; Other
• Patient Sex: Female