MAUDE Adverse Event Report: MINERVA SURGICAL INC MINERVA ENDOMETRIAL ABLATION SYSTEM- DISPOSABLE HANDPIECE

Catalog Number	MIN9770
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 of the disposable handpiece was not provided; therefore a device history could not be performed.The relationship between the device and the reported adverse event could not be established.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.Patss is a rare complication following a global endometrial ablation in woman who have had a previous tubal sterilization.The minerva endometrial ablation system operators manual includes post-ablation tubal sterilization syndrome as a potential adverse event and includes the following warning."patients who undergo endometrial ablation procedures who have previously undergone tubal ligation are at increased risk of developing post ablation tubal sterilization syndrome which can require hysterectomy.This can occur as late as 10 years post procedure.".
Event or Problem Description
It was reported about nine months ago, exact date unknown, the treating physician performed a minerva ablation on a patient.The patient developed post ablation tubal sterilization syndrome (patss).The physician attempted to rectify patss hysteroscopically, however was unsuccessful.The patient had to undergo a supracervical hysterectomy.

• Brand Name: MINERVA ENDOMETRIAL ABLATION SYSTEM- DISPOSABLE HANDPIECE
• 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: 19226836
• Report Number: 3011011193-2024-00008
• Device Sequence Number: 20553646
• Product Code: MNB
• UDI-Device Identifier: 00862393000162
• UDI-Public: 00862393000162
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2024

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: MIN9770
• 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: 04/04/2024
• Initial Report FDA Received Date: 05/01/2024
• 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