MAUDE Adverse Event Report: MINERVA SURGICAL, INC. MINERVA ENDOMETRIAL ABLATION SYSTEM, DISPOSABLE HANDPIECE; ENDOMETRIAL ABLATION DEVICE

Catalog Number	MIN9770
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that in (b)(6) 2024 (exact date unknown) a minerva endometrial ablation procedure was performed in a patient suffering from aub and bacterial vaginosis.Following an uneventful ablation procedure, the patient developed endometritis and underwent a hysterectomy.
Additional Manufacturer Narrative
Multiple attempts were made (via email and phone) to collect additional information on the reported case have been made.All remained unanswered.No additional information is available.The disposable handpiece used in this case was not returned and therefore a failure analysis of the complaint device could not be performed.Based on the reported information the device was used off-label.Minerva ablation system is contraindicated for use in a patient with an active genital or urinary tract infection.The operator's manual specifically states: · section 5.0 contraindications - the minerva endometrial ablation system is contraindicated for use in a patient with active genital or urinary tract infection at the time of the procedure (e.G., cervicitis, vaginitis, endometritis, salpingitis or cystitis).· section 8.1.3 methods / exclusion criteria - active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure.

• Brand Name: MINERVA ENDOMETRIAL ABLATION SYSTEM, 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: rachel nankervis ; 4255 burton drive; santa clara, CA 95054
• MDR Report Key: 21942659
• Report Number: 3011011193-2025-00006
• Device Sequence Number: 20928245
• Product Code: MNB
• UDI-Device Identifier: 00862393000162
• UDI-Public: 00862393000162
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/07/2025

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
• Device Catalogue Number: MIN9770
• Device Lot Number: UNKNOWN
• 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: 04/09/2025
• Initial Report FDA Received Date: 05/01/2025
• 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
• Patient Sex: Female