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	07/16/2026
Type of Reportable Event	Serious Injury

• 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 ; +1(650)284-3500
• MDR Report Key: 50241948
• Report Number: 3011011193-2026-00010
• Device Sequence Number: 10267850
• Product Code: PGT
• UDI-Device Identifier: 00850033976076
• UDI-Public: 00850033976076
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 08/13/2026

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
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 08/13/2026
• 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: Required Intervention; Life Threatening
• Patient Sex: Female