MAUDE Adverse Event Report: MINERVA SURGICAL, INC. GENESYS HTA ENDOMETRIAL ABLATION SYSTEM

Model Number	M006580210
Medical Device Problem Codes	Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No adverse event was reported.Subject device was returned for further investigation.It has been confirmed the procerva sheath end component detached from the device, potentially due to process workmanship defect, which resulted in the flow of hot saline from system.Although there is no reported adverse event, an mdr is being submitted as a malfunction report because it has been concluded that this device failed to perform as intended.The sheath end is not designed to detach during use.If this defect were to reoccur, there is a potential for the device to cause or contribute to a serious injury (burn).Production and complaint records were reviewed and it was determined to be an isolated issue and there are no reports of other complaints in this lot for the same failure mode.
Event or Problem Description
It was reported the procerva sheath end detached during use and hot saline was coming out.The hot saline did not contact the patient or the user.No injuries reported.

• Brand Name: GENESYS HTA ENDOMETRIAL ABLATION SYSTEM
• Common Device Name: ENDOMETRIAL ABLATION SYSTEM
• 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: 16501135
• Report Number: 3011011193-2023-00004
• Device Sequence Number: 16982585
• Product Code: MNB
• UDI-Device Identifier: 08714729809456
• UDI-Public: 08714729809456
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P000040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2023

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 Expiration Date: 03/20/2024
• Device Model Number: M006580210
• Device Catalogue Number: M006580210
• Device Lot Number: 29130755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Female