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

Catalog Number	MIN9770
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Bowel Burn (1756); Burn(s) (1757); Uterine Perforation (2121)
Date of Event	04/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on an interview performed by minerva surgical, the patient had a severely anteflexed uterus.Diagnostic hysteroscopy pre- or post-procedure was not performed.Multiple attempts were made to obtain an update on the patient status.All remained unanswered.No additional information is available.It is possible that the uit did not miss the perforation because full perforation was not present.The likely scenario and potential root cause of this complication is related to device being mal-positioned deep in the myometrium but without a full thickness perforation at the time of the uit, which in turn allowed for it to pass.Under this scenario a transmural burn with formation of a mechanical perforation during the energy delivery cycle is possible and may result in unintended thermal effect on the organs of the viscera.The disposable handpiece used in this case was not returned and therefore a failure analysis of the complaint device could not be performed.Perforations and injuries such as thermal injuries 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.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.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.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.It has been reported in the literature that patients with a severely anteverted, retroflexed or laterally displaced uterus are at greater risk of uterine wall perforation during any intrauterine manipulation.A false passage can occur during any procedure in which the uterus is instrumented, especially in cases of a severe anteverted, retroflexed or a laterally displaced uterus.Use caution to ensure that the minerva disposable handpiece is properly positioned in the uterine cavity.
Event or Problem Description
On april 4, 2025 it was reported that a minerva endometrial ablation procedure was performed on (b)(6) 2025.One to two days after the ablation procedure the patient returned to the doctor with severe abdominal pain.Laparotomy revealed a uterine perforation on the posterior uterine wall and thermal damage to the small bowel.Subsequently minerva surgical received mw5168793 on april 23, 2025 from fda.The medwatch report represents the same event.Per medwatch, "patient found to have perforated bowels and uterus and burns to uterus, fallopian tubes, and bowels." small bowel resection with end-to-end anastomosis and hysterectomy were performed.

• Brand Name: MINERVA ENDOMETRIAL ABLATION SYSTEM, DISPOSABLE HANDPIECCE
• 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: 21942523
• Report Number: 3011011193-2025-00005
• Device Sequence Number: 20970911
• Product Code: MNB
• UDI-Device Identifier: 00862393000162
• UDI-Public: 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: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/02/2025

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: 04/04/2025
• 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; Life Threatening
• Patient Sex: Female