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

Model Number MIN9770

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Uterine Perforation (2121); Bowel Perforation (2668)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturer contacted the physician to obtain additional information related to this event.Details of the procedure weren't available secondary to the extended time that passed since the incident occurred, and there was only a partial migration of patient charts to the new electronic medical records.Uterine perforations are known complications of endometrial ablation.Complications associated with uterine 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.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, and it might not detect all perforations.Clinical judgment must always be used.As with all endometrial ablation procedures, serious injury or death can occur, including but not limited to thermal injury to adjacent tissue, such as bowel, bladder, vagina, vulva, and/or perineum.The disposable handpiece used in this case was not returned, therefore a failure analysis of the complaint device cannot be completed.The lot number of the disposable handpiece was not provided; therefore a device history record review could not be performed.However, all surgical handpieces meet all the specifications when released, including adequate sterilization.The relationship between the device and the reported adverse event could not be established.

Event Description

Company representative was informed recently that five years ago a patient underwent an endometrial ablation procedure and at the time of post-ablation hysteroscopy, a uterine perforation was diagnosed.Laparoscopy confirmed uterine perforation and damage to the bowel (details unknown).Laparotomy and end-to-end anastomosis were performed.Patient recovered and was discharged.

• Brand Name: MINERVA SURGICAL ENDOMETRIAL ABLATION SYSTEM
• Type of Device: 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: 14780378
• MDR Text Key: 294615421
• Report Number: 3011011193-2022-00006
• Device Sequence Number: 1
• Product Code: MNB
• UDI-Device Identifier: 00862393000162
• UDI-Public: (01)00862393000162
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MIN9770
• Device Catalogue Number: MIN9770
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Female