MAUDE Adverse Event Report: MINERVA SURGICAL, INC. MINERVA SINGLE STERILE DISPOSABLE HANDPIECE; DEVICE, THERMAL ABLATION, ENDOMETRIAL

Model Number	MIN9770
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Error code 002 came up with eight seconds left.

• Brand Name: MINERVA SINGLE STERILE DISPOSABLE HANDPIECE
• Common Device Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): MINERVA SURGICAL, INC.; 4255 burton drive; santa clara CA 95054
• MDR Report Key: 19257792
• Report Number: 19257792
• Device Sequence Number: 12385340
• Product Code: MNB
• UDI-Device Identifier: 00862393000162
• UDI-Public: (01)00862393000162
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/12/2024
• Report Date (Section F): 03/12/2024

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
• Device Model Number: MIN9770
• Device Catalogue Number: MIN9770
• Device Lot Number: 23H21-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 05/06/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2024
• 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: 45 YR
• Patient Sex: Female
• Date Report Sent to FDA: 03/12/2024