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

Model Number	M00658001R0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a genesys hta procedure was performed in a patient suffering from aub.At about six minutes into the ablation cycle, a small amount of fluid migrating from the uterine cavity was noted.Out of abundance of caution doctor appropriately stopped the procedure.A small area of mucosal blanching on the cervix at 4-6 o'clock, with no evidence of vaginal or any other unintended thermal effect was noticed, treated with application of silver sulfadiazine topical cream and estrace (estradiol) vaginal cream.The initially observed unintended thermal effect on the cervix completely resolved five days later.
Additional Manufacturer Narrative
Manufacturer contacted the physician to obtain additional information related to this event.It was reported the patient sustained a 1st degree cervical burn.No medical or surgical intervention, beyond the application of the topical cream, was required.Per agreement between fda and manufacturer, effective october 27th, 2008, a 1st degree burn shall be reported to fda as a malfunction event type.Patient was seen in the office for her post-operative visit on october 18th and physician reported the burn was fully healed.The genesys hta system (control unit and procerva procedure set) was returned to the manufacturer for evaluation.Evaluation was performed at the system level.The system successfully passed all system checks and determined to have operated as intended.The fluid leak at the cervix is most likely caused by an inadequate cervical seal which was immediately noticed by the physician and procedure was aborted.A review of the data log indicated there was a fluid loss of 1-2cc in volume, prior to the procedure being aborted, which is below the predetermined threshold for the system to alarm.The relationship between the system and the reported adverse event could not be established.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".

• Brand Name: GENESYS HTA ENDOMETRIAL ABLATION SYSTEM, REFURBISHED CONTROL UNIT
• 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: 15781515
• Report Number: 3011011193-2022-00014
• Device Sequence Number: 20483364
• Product Code: MNB
• UDI-Device Identifier: 08714729809357
• UDI-Public: 08714729809357
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/11/2022

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: M00658001R0
• Device Catalogue Number: M00658001R0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2017
• 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