MAUDE Adverse Event Report: MINERVA SURGICAL, INC. MINERVA ES DISPOSABLE HANDPIECE; 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	07/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 customer so device history review was not performed, the handpieces met all qa specifications prior to being released, including adequate sterilization.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 an absorbable hemostatic powder for a uterine perforation is at the physician's discretion and does not indicate the severity of the perforation.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.
Event or Problem Description
It was reported that post a laparoscopic salpingectomy, the treating physician attempted an endometrial ablation using a minerva es device.The uterine integrity test (uit) was attempted twice and failed both times.The treating physician re-entered one of the existing laparoscopic ports to visualize the uterus where a uterine perforation was observed.A decision was made to prophylactically use an absorbable hemostatic powder on the perforation and the ablation was aborted.

• Brand Name: MINERVA ES 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: 22699650
• Report Number: 3011011193-2025-00011
• Device Sequence Number: 8944706
• Product Code: MNB
• UDI-Device Identifier: 00862393000162
• UDI-Public: 00862393000162
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 08/05/2025

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
• 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: 07/10/2025
• Initial Report FDA Received Date: 08/04/2025
• 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: Other
• Patient Sex: Female