MAUDE Adverse Event Report: MINERVA SURGICAL, INC. MINERVA ES ENDOMETRIAL ABLATION SYSTEM; ENDOMETRIAL ABLATION DEVICE

Model Number	MIN180S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Uterine Perforation (2121); Peritonitis (2252); Bowel Perforation (2668)
Date of Event	02/25/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Manufacturer received medwatch report, (b)(4), on june 22nd, 2022, from fda for same event.It is filed using the mandatory medwatch reporting program and therefore the same event (described in this report) will appear twice on the maude database.Manufacturer has made and documented multiple attempts to communicate with the facility by phone and in writing.Multiple requests for patient chart, name of medical provider, other were refused with internal policies being cited as the reason for refusal.Minimal information regarding the endometrial ablation procedure and outcome is known.Uterine/bowel perforations are known complications of endometrial ablation.Complications associated with perforations are addressed in the warning section of the operator's manual and instructions for use, including the statements: use caution not to perforate the uterine wall when sounding, dilating, or inserting the disposable handpiece.Activation of the minerva disposable handpiece in the setting of a uterine perforation is likely to result in serious patient injury.Excessive force applied during placement of the disposable handpiece may result in tissue injury, including perforation.Although designed to detect a perforation of the uterine wall, this test is an indicator only, and it might not detect all perforations.Clinical judgment must always be used.Post-treatment, any patient-reporting signs/symptoms that could indicate a serious complication, e.G., bowel injury, should be thoroughly evaluated without delay.As with all endometrial ablation procedures, serious injury or death can occur, including but not limited to, infection and injury to adjacent tissue, such as bowel, bladder, vagina, vulva, and/or perineum.There were no reports of system errors during the procedure.Minerva surgical requested and received the controller for evaluation.Controller passed all testing during investigation and performed as expected.The controller's uterine integrity test (uit) is performed prior to activation of the ablation phase.The uit is only an indicator of a suspected perforation when alarmed and may not detect all perforations, as stated in the operator's manual.Clinical judgement must always be used.The disposable handpiece used in this case is not available to be returned; therefore, a failure analysis of the minerva es handpiece could not be completed.
Event or Problem Description
Manufacturer received medwatch report, (b)(4), on june 22nd, 2022, from fda for same event.This report is filed using the mandatory medwatch reporting program and therefore the same event (described in this report) will appear twice on the maude database.The original facility reported event description of medwatch stated, "the co2 and uterine cavity checks were performed twice without any alert to perforation and indicated the cavity was intact.Never any signal from the device or alerts that there could have been a problem".No report of event was received by manufacturer from the user facility.This report reflects the results of manufacturer investigation for the event previously reported by the facility.Manufacturer has made and documented multiple attempts to communicate with the facility by phone and in writing.Multiple requests for patient chart, name of medical provider, other were refused with internal policies being cited as the reason for refusal.Facility was informed in writing that according to 45 cfr 164.512(b)(1)(iii) the health and accountability act of 1996 ("hippa") includes a specific exception which allows a "covered entity" (e.G., physician, hospital) to disclose, without prior patient authorization, a patient's "protected health information" ("phi") to a manufacturer for activities relating to adverse event reporting or other public health related purposes.Despite that, facility insisted on following its internal policies and refused to provide information about the procedure or name of the medical professional.However, manufacturer was able to obtain some minimal clarification and corrected information, from a facility contact, pertaining to the event that which was either incorrect or missing on the user facility's medwatch form, such as: date of death: late (b)(6) (day of discharge) or early morning (b)(6) 2022.Medwatch date of death date was left blank.Endometrial ablation procedure was confirmed to have occurred on (b)(6) 2022.Preexisting medical conditions section was incomplete.It was communicated, that the patient suffering from aub also had several co-morbidities (scleroderma, severe pulmonary arterial hypertension, interstitial lung disease (ild), chronic hypoxemia, esophageal dysphagia).It was communicated, the patient had reported an increase in pain during her initial hospitalization ((b)(6) 2022) but was managed with medications, and overall improved prior to discharge home two days after the procedure, on (b)(6) 2022.Per family, it was reported to the physician office that patient passed away sometime late (b)(6) 2022 (day of discharge from the facility) or early morning (b)(6) 2022.Facility also informed that cod was peritonitis secondary to bowel perforation.Facility informed manufacturer that it made an error in its original medwatch report to the fda, indicating that the manufacturer was informed of this event.Facility confirmed that the manufacturer was never notified about this event.It was also reported that between the date of the event of (b)(6) 2022, the equipment used in this case continued to be used by the facility without incident or complications.

• Brand Name: MINERVA ES ENDOMETRIAL ABLATION SYSTEM
• Common Device Name: ENDOMETRIAL 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: veronica williams ; 4255 burton drive; santa clara, CA 95054 ; 6503991771
• MDR Report Key: 15077668
• Report Number: 3011011193-2022-00008
• Device Sequence Number: 4784936
• Product Code: MNB
• UDI-Device Identifier: 00862393000100
• UDI-Public: 00862393000100
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P140013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2022

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: MIN180S
• Device Catalogue Number: MIN180S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2018
• 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: Hospitalization; Death
• Patient Age: 41 YR
• Patient Sex: Female