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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the physician had completed the resection and was removing the device from the patient when it was discovered that the device had detached into two pieces.The physician successfully retrieved the detached tip from the patient.No patient harm was reported.
Additional Manufacturer Narrative
The lot number was provided, and a product history review identified no nonconformance that could have contributed to the reported complaint.The device is pending return and evaluation.If the results of the investigation lead to additional information, a supplemental report will be filed.The ifu symphion system general warning and precaution: -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.-excessive force on the resecting device tip does not improve resection performance and may increase the risk of perforation or device damage.-do not allow the tip of the resecting device to touch any hard object.If such contact does occur, inspect the tip.If there are cracks, fractures, or if there is any other reason to suspect the tip is damaged, replace the resecting device immediately.-excessive force applied during insertion or removal of the resecting device may result in device damage or tissue injury including perforation.-insertion and removal of the resecting device should always be under direct visualization.

• 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: 50792416
• Report Number: 3011011193-2026-00014
• Device Sequence Number: 9415585
• 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): 09/16/2026

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 Catalogue Number: FG-0201
• Device Lot Number: 118254228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2025
• 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: Other
• Patient Sex: Female