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

Model Number	M006580210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer contacted the physician to obtain additional information related to this event.The physician stated that the system did not malfunction as it alerted her of the fluid loss as designed.It was confirmed the patient sustained a 2nd degree burn to the vagina.The physician reported the patient was hospitalized for pain management for less than 48 hours.Per agreement between fda and manufacturer, effective october 27th, 2008, a 2nd degree burn, not classified as "extensive" and does not involve both internal and external anatomy, shall be reported to fda as a malfunction event type.Based on the information reviewed, there is no indication of a product deficiency.All handpieces meet all qa specifications prior to being released, including adequate sterilization.The ifu instructs the user to "during ablation, the saline temperature continues to rise until 90°c is reached, and the user must continuously: monitor the cervical seal for fluid loss and to confirm a tight cervical seal.Maintain a stable procedure sheath position throughout the procedure.Monitor the screen for fluid loss level." warnings and cautions related to an event of this nature are included in the ifu for genesys hta, including but not limited to: "the physician must maintain control of the procedure sheath (i.E., not hand off to another individual) for the duration of the treatment to avoid compromising the cervical seal.A compromise of the cervical seal could result in fluid leakage through the cervix, which could result in thermal injury to surrounding tissue"."do not place the procedure sheath tubing over the patient's leg or in contact with any part of the user's or patient's anatomy, as the tubing carries hot fluid and contact could result in thermal injury.The temperature of the tubing could be up to 55°c." "throughout the procedure, carefully observe the junction of the procedure sheath with the external cervical os to confirm a tight cervical seal and that there is no fluid leakage".
Event or Problem Description
It was reported the system alerted the physician of fluid loss three times throughout the treatment cycle.The physician did not notice a cervical leak of fluid until the third alert when the treatment cycle was aborted.Physician observed fluid on the cervix and the posterior of the vaginal wall.Once completed, a small vaginal burn was noted.

• Brand Name: GENESYS HTA ENDOMETRIAL ABLATION SYSTEM
• Common Device Name: ENDOMTRIAL 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: 16452509
• Report Number: 3011011193-2023-00003
• Device Sequence Number: 5859989
• Product Code: MNB
• UDI-Device Identifier: 08714729809456
• UDI-Public: 08714729809456
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/28/2023

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 Expiration Date: 02/16/2024
• Device Model Number: M006580210
• Device Catalogue Number: M006580210
• Device Lot Number: 28956305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Hospitalization
• Patient Sex: Female