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

Model Number	MIN9770
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Bowel Burn (1756); Uterine Perforation (2121)
Date of Event	10/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2024 the patient started experiencing sharp lower abdominal pain and went to the er.After evaluation, which among others included diagnostic laparoscopy, the patient was diagnosed with a fundal uterine perforation and a thermal injury to the small intestine.Small bowel resection and end-to-end anastomosis were performed.In addition, the uterine perforation was repaired.The patient recovered well and was discharged on (b)(6) 2024.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.The lot number was provided by the customer and a device history review was performed.The handpieces met all qa specifications prior to being released, including adequate sterilization.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.
Event or Problem Description
It was reported that the physician performed an endometrial ablation procedure on (b)(6) 2024.On (b)(6) 2024, the patient returned to the emergency department where the patient reported symptoms including pelvic pain, nausea, and vomiting.Uterine perforation and thermal effect on the bowel was confirmed.

• Brand Name: MINERVA ENDOMETRIAL ABLATION SYSTEM, DISPOSABLE HANDPIECE
• Common Device Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• 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: 20581727
• Report Number: 3011011193-2024-00016
• Device Sequence Number: 15477771
• Product Code: MNB
• UDI-Device Identifier: 00862393000162
• UDI-Public: 00862393000162
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/31/2024

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 Expiration Date: 04/12/2026
• Device Model Number: MIN9770
• Device Catalogue Number: MIN9770
• Device Lot Number: 24D12-02
• 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: 10/04/2024
• Initial Report FDA Received Date: 10/31/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Sex: Unknown