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

Catalog Number	M006580210
Medical Device Problem Codes	Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the physician experienced a fluid leak during the procedure.The system declared a leak alarm at approximately 3 minutes and 30 seconds into the ablation cycle.Around this time, the physician noticed fluid pooling into the vaginal canal.The procedure was aborted.The system went through a 1 minute and 30 seconds cool down cycle prior to the removal of the instruments.The physician saw the patient in the office post operatively and noted a vaginal burn and a burn to the right buttocks.The patient was prescribed vaginal cream, topical cream, and prophylactic oral antibiotics.It was reported that the physician experienced a fluid leak during the procedure.The system declared a leak alarm at approximately 3 minutes and 30 seconds into the ablation cycle.Around this time, the physician noticed fluid pooling into the vaginal canal.The procedure was aborted.The system went through a 1 minute and 30 seconds cool down cycle prior to the removal of the instruments.The physician saw the patient in the office post operatively and noted a vaginal burn and a burn to the right buttocks.The patient was prescribed vaginal cream, topical cream, and prophylactic oral antibiotics.
Additional Manufacturer Narrative
The physician indicated that a speculum was used during the procedure.The reported injury may have been cause by an insufficient cervical seal with hot fluid continuous leaking during the 1 minute and 30 second cool down period and/or the instruments may have been prematurely removed prior to the fluid in the uterus reaching 45°c.Fluid cool down could take up to 10 minutes in certain situations.All of which are possible causes of reported event.However, the exact root cause could not be determined.The disposable handpiece used in this case was not returned and therefore a failure analysis of the complaint device could not be performed.The lot number was not provided and therefore a device history review could not be performed, the handpieces met all qa specifications prior to being released, including adequate sterilization.The ifu instructs the user as follows: "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: - if system cooling is not possible (i.E., power loss), do not remove the procedure sheath from the patient until fluid in the uterus has cooled.It may take up to 10 minutes to ensure that fluid temperature in the uterus is below 45°c.Exercise care when handling the procedure set, because the fluid may still be hot.- neither advance nor withdraw the procedure sheath into or out of the uterine cavity once heating has begun until the cooling is complete; - be aware of the appropriate sequence of actions to halt, resolve and/or continue the treatment, in the event the genesys hta system detects a fluid loss of 10 ml; - warning: if cancelling the procedure from ablation, the fluid in the tubing and uterus is still hot.Maintain stable sheath position and do not remove the procedure sheath until prompted by the genesys hta¿ system.The system prompt indicates that patient and system cooling is complete, and it is safe to remove the procedure sheath.- if heated fluid leaks onto the patient, flush the area with cool saline.It is important to assess the area in order to determine if a burn is present.If a burn is present, determine the severity and an appropriate treatment should be made per the standard of care of your facility.It is also recommended that the area be assessed again at follow-up.

• Brand Name: GENESYS HTA ENDOMETRIAL ABLATION SYSTEM, PROCERVA PROCEDURAL SET
• 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 gosselin ; 4255 burton drive; santa clara, CA 95054 ; 9787601704
• MDR Report Key: 20258999
• Report Number: 3011011193-2024-00013
• Device Sequence Number: 7742275
• Product Code: MNB
• UDI-Device Identifier: 00850033976038
• UDI-Public: 00850033976038
• 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): 08/18/2024

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 Catalogue Number: M006580210
• Device Lot Number: UNKNOWN
• 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: 08/20/2024
• Initial Report FDA Received Date: 09/19/2024
• 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