MAUDE Adverse Event Report: MINERVA SURGICAL, INC. GENESYS HTA ENDOMETRIAL ABLATION SYSTEM, PROCERVA PROCEDURAL SET; DEVICE, THERMAL ABLATION, ENDOMETRIAL

Model Number	M006580210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Burning Sensation (2146)
Date of Event	03/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer contacted the physician to obtain additional information related to this event.Upon analysis of event, it has been concluded that the thermal effect is highly unlikely to be a result of fluid leak at the cervix.This conclusion was based on several factors: 1.Fluid loss was never observed by physician.2.Fluid loss was never reported by the respective feature of the genesys system 3.If fluid loss would be the cause, the thermal effect would involve the vaginal mucosa first and would likely affect the posterior wall of the vagina.Based on the above and considering the lateral labial location of the above-named effect, it is more likely that thermal energy affected the tissue secondary to direct contact between the sheath of the device and the skin.While the physician reportedly did not remove the speculum during the ablation cycle, it is possible that some of the tissue inadvertently established temporary contact with the sheath, resulting in unintended thermal effect.This scenario is more likely to occur in a higher bmi patient population, which this patient was.No additional medical intervention, beyond the application of the topical cream, was recommended by physician.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".The procedure set was discarded and was not returned for evaluation.The lot number of the procedure set was not provided; therefore, a device history record review could not be performed.However, all surgical procedure sets meet all qa specifications when released, including adequate sterilization.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported a patient experienced a burning sensation during urination post genesys hta procedure.Physician reported no malfunction or alarm by the system during the procedure and no fluid leak was noted.Physician characterized the thermal effect to be minor in nature and recommended application of silver sulfadiazine topical cream.

• Brand Name: GENESYS HTA ENDOMETRIAL ABLATION SYSTEM, PROCERVA PROCEDURAL SET
• Common Device Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• 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: veronica williams ; 4255 burton drive; santa clara, CA 95054
• MDR Report Key: 14360291
• Report Number: 3011011193-2022-00005
• Device Sequence Number: 4077638
• Product Code: MNB
• UDI-Device Identifier: 08714729809456
• UDI-Public: 08714729809456
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/11/2022

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: M006580210
• Device Catalogue Number: M006580210
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Female