MAUDE Adverse Event Report: MINERVA SURGICAL, INC. SYMPHION OPERATIVE HYSTEROSCOPY SYSTEM, RESECTING DEVICE; CLOSED LOOP HYSTEROSCOPIC INSUFFLATOR WITH CUTTER-COAGULATOR

Catalog Number	FG-0201
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Uterine Perforation (2121)
Date of Event	06/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the physician entered the cavity with the symphion scope.Navigation through the cervix was difficult due to suspected cancerous tumors, and the physician was unable to identify internal uterine landmarks.Shortly after the scope introduction, the symphion resecting device was opened and introduced.The physician was able to clean certain parts of the cavity after entering and exiting the uterine cavity multiple times.During repeated device entry and exit, a perforation near the fundus was observed.The procedure was aborted, and the laparoscopy procedure was performed to stop the bleeding.Reportedly, the patient was stable and doing fine after surgery.No further medical intervention has been reported at this time.
Additional Manufacturer Narrative
No product malfunction or issue was reported, and the resecting device used in this case was discarded.No relevant information was identified during the lot history review that could have contributed to the reported event.Based on the available information, the relationship between the device and the reported adverse event could not be established.The symphion operator's manual lists general contraindication and warning: - pregnancy, genital tract infections, and known uterine cancer are contraindications to hysteroscopy.- the symphion system should only be used by physicians trained in hysteroscopy and hysteroscopic surgery using powered instruments.Healthy tissue can be injured, e.G., perforation by improper use of the resecting device.Use every available means to avoid such injury.- do not operate the resecting device without clear visualization.The device resecting window area should be in the field of view while the resecting device is operating.If visualization is lost at any point during the procedure, resection/coagulation must be stopped immediately.- insertion and removal of the resecting device should always be under direct visualization.- resecting device precautions: excessive force on the resecting device tip does not improve resection performance and may increase the risk of perforation or device damage.Excessive force applied during insertion or removal of the resecting device may result in device damage or tissue injury, including perforation.- if bleeding occurs, advance the active electrode of the resecting device to the source of the bleeding and depress the blue coag foot pedal to activate coagulation.- section 7 adverse events lists the potential complications of continuous flow endoscopic surgery, including uterine perforation and bleeding.

• Brand Name: SYMPHION OPERATIVE HYSTEROSCOPY SYSTEM, RESECTING DEVICE
• Common Device Name: CLOSED LOOP HYSTEROSCOPIC INSUFFLATOR WITH CUTTER-COAGULATOR
• 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: angela gonzalez ; 4255 burton drive; santa clara, CA 95054 ; 6502843500
• MDR Report Key: 25818740
• Report Number: 3011011193-2026-00008
• Device Sequence Number: 16111433
• Product Code: PGT
• UDI-Device Identifier: 00850033976076
• UDI-Public: 00850033976076
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/14/2026

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 Catalogue Number: FG-0201
• Device Lot Number: 119646075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2026
• 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; Required Intervention
• Patient Sex: Female