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	02/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, there is no indication of a product deficiency that could have contributed to the reported injury.The reported detachment of the rd outer tip most likely occurred after the physician decided to remove the rd due to profuse bleeding, which prevented the physician from maintaining a clear view to continue the procedure.As reported, when the physician decided to withdraw the hysteroscope, the device's tip came with it.The physician retrieved the detached tip from the vagina.Despite multiple attempts to retrieve the product for evaluation, the account has chosen not to release the device due to internal protocol.A product history review identified no nonconformance that could have contributed to the reported injury.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.Clinical observation (e.G., vital signs and physical examination) and visualization of filtered/returned fluid is 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 listed the potential complications of continuous flow endoscopic surgery include uterine perforation and bleeding.
Event or Problem Description
It was reported that the physician performed a d&c and symphion procedure in a nulliparous, postmenopausal patient suffering from aub (l).The cervix was extremely small, and the physician spent an hour to achieve the dilation for the symphion hysteroscope insertion.No clear visualization was achieved, and the physician was not sure where exactly in the uterine cavity she was located.Despite all efforts, a clear visualization was never established, and the bleeding source was not identifiable hysteroscopically.At some point, the distention media bag became empty, and dr.Akin requested that a second bag be connected.Despite the axora representative's advice, the second bag was connected and used.Unsuccessful attempts were made to clear the view, so the physician decided to remove the resecting device (rd).While withdrawing the device, the physician noted that the rd tip did not move.She prudently decided to withdraw the hysteroscope, and the tip of the rd came with it, out to the vagina, and was taken out from the cavity.Due to continuous and profuse bleeding, the physician elected to perform a hysterectomy during which a uterine perforation at the fundus of the uterus, next to a very large subserosal fibroid, was identified.The treating physician indicated that the uterine perforation was most likely inflicted with the curette during d&c and not by the rd.

• 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: 24537320
• Report Number: 3011011193-2026-00004
• Device Sequence Number: 21416952
• Product Code: PGT
• UDI-Device Identifier: 00850033976076
• UDI-Public: 00850033976076
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/06/2026

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: 117371672
• 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: 02/12/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2025
• 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: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Female