MAUDE Adverse Event Report: MINERVA SURGICAL, INC. SYMPHION RESECTING DEVICE; INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA

Model Number	FG-0201
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the surgery, the handle of the symphion resection device snapped at the handle.The broken piece remained separate from the patient.No patient harm.

• Brand Name: SYMPHION RESECTING DEVICE
• Common Device Name: INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA
• Manufacturer (Section D): MINERVA SURGICAL, INC.; 4255 burton drive; santa clara CA 95054
• MDR Report Key: 24290784
• Report Number: 24290784
• Device Sequence Number: 10381694
• Product Code: PGT
• UDI-Device Identifier: 00850033976076
• UDI-Public: (01)00850033976076(17)260814(10)116008871
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2026
• Report Date (Section F): 02/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FG-0201
• Device Catalogue Number: FG-0201
• Device Lot Number: 116008871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Date Report Sent to FDA: 02/04/2026