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	02/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the symphion operative hysteroscopy for a myomectomy procedure on (b)(6) 2026, after 30 minutes of resection, the system alerted to replace the first device.During resection using a second device, the sales representative noticed an increase in bleeding and fluid deficit.She pointed this out to the physician and asked whether the physician still had visibility; otherwise, she should not proceed.The physician decided to stop the procedure.On (b)(6) 2026, the representative was informed by other physicians that there was a perforation, and either late that night or the next day, the patient had to go back to the hospital, spend some time there for an additional procedure related to blood in the abdomen.The patient was released (date unknown) and is doing ok.On (b)(6) 2026, during a follow-up, the treating physician reported that the patient is doing well now and she has no concerns.The doctor did treat the patient for the perforation but was not willing to go into details about what was done.No additional information is available.
Additional Manufacturer Narrative
The information provided within this report is based on the sales representative who was present in the operating room.On (b)(6) 2026, the representative contacted the treating physician and learned that the perforation was treated; however, the treating physician would not release any details.The resecting device used in this case was discarded post-procedure, and therefore, a failure analysis of the subject device could not be performed.The lot number was not provided; therefore, a device history review could not be performed.However, all devices are verified to meet all qa specifications prior to being released, including adequate sterilization.Based on the available information, the relationship between the device and the reported adverse event could not be established.The ifu symphion system general warning: - 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.- nsertion 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.- linical observation (e.G., vital signs and physical examination) and visualization of filtered/returned fluid are recommended to reduce the risk of blood loss and excessive bleeding.To maintain visualization during coagulation, fluid will be circulated at 10-second intervals while coagulation is active.- 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: 24651324
• Report Number: 3011011193-2026-00005
• Device Sequence Number: 13264077
• Product Code: PGT
• UDI-Device Identifier: 00850033976076
• UDI-Public: 00850033976076
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 03/20/2026

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
• 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: 02/27/2026
• Initial Report FDA Received Date: 03/20/2026
• 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: Hospitalization; Other
• Patient Sex: Female