MAUDE Adverse Event Report: MINERVA SURGICAL, INC. MINERVA ES ENDOMETRIAL ABLATION SYSTEM; ENDOMETRIAL ABLATION DEVICE

Model Number	MIN180S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	12/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The minerva es endometrial ablation system used in this case was returned and a failure analysis of the suspect device was performed and determined no device issue was found.A device history record review was performed and revealed no non-conformities that would have contributed to the reported event.The relationship between the device and the reported adverse event could not be established.Vasovagal reactions are not uncommon in these types of procedures.Based on the available information and the medical opinion of the practicing physician, there is no indication a product deficiency was directly related to the reported adverse event.
Event or Problem Description
It was reported that user performed an endometrial ablation procedure on a patient suffering from aub(e).The procedure was performed under very light sedation.With 10 seconds remaining of the ablation cycle, the patient experienced a vasovagal reaction and became unresponsive.Patient was taken to the er department, kept for observation for 12 hours, fully recovered and discharged.

• Brand Name: MINERVA ES ENDOMETRIAL ABLATION SYSTEM
• Common Device Name: ENDOMETRIAL ABLATION DEVICE
• 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: michelle becker ; 4255 burton drive; santa clara, CA 95054
• MDR Report Key: 16244937
• Report Number: 3011011193-2023-00001
• Device Sequence Number: 15091221
• Product Code: MNB
• UDI-Device Identifier: 00862393000100
• UDI-Public: 00862393000100
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P140013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/25/2023

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 Model Number: MIN180S
• Device Catalogue Number: MIN180S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2022
• Initial Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female