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

Catalog Number	MIN9770
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Uterine Perforation (2121)
Date of Event	02/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the treating physician had originally sounded the patient to a total length of 5.5.Due to the patient having an anteverted uterus, the physician determined that was incorrect and resounded the patient to a sound length of 9.The minerva handpiece was inserted and performed the uterine integrity test (uit) which failed.The physician used a scope and identified a perforation inside the uterus at the left cornu.The procedure was then aborted and no energy was delivered to the patient.The doctor sealed the perforation laparoscopically.
Additional Manufacturer Narrative
Minerva surgical conducted an interview with the treating physician on 3/3/2025 to gather additional information.The treating physician noted that the body of the uterus had an approximately 90 degrees rotation along its longitudinal axis, with one cornu being adhered to the anterior abdominal wall.The physician suspects that this rotational change in anatomical position could have been a result of prior surgeries (c-section and surgery on fallopian tube) and suspects this may have been the cause behind the infliction of the perforation.Physician elected to manage the perforation by applying oxidized regenerated cellulose (orc) and bipolar coagulation to control or prevent capillary bleeding.The patient fully recovered and is doing well.Note: possible causes of uterine perforation could be a result of sounding, dilation, or handpiece insertion and was appropriately detected by the uit.The use of orc for a uterine perforation is at the physician's discretion and does not indicate the severity of the perforation.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 device history review, there were no ncrs, deviations, or rework activity noted in the dhr for this unit or lot number potentially related to the reported failure.The handpieces in this lot met 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.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.

• Brand Name: MINERVA DISPOSABLE HANDPIECE, STERILE
• 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: 21560999
• Report Number: 3011011193-2025-00003
• Device Sequence Number: 4430949
• 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): 03/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: MIN9770
• Device Lot Number: 24J30-010
• 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: 03/19/2025
• Initial Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2024
• 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