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

Catalog Number MIN9770

Device Problem Use of Device Problem (1670)

Patient Problems Bowel Burn (1756); Uterine Perforation (2121); Bowel Perforation (2668)

Event Date 08/24/2023

Event Type  Injury  

Manufacturer Narrative

Based on the information reviewed, there is no indication of a product deficiency directly related to the reported adverse event.The more likely cause of the perforation was related to the device being malpositioned deep within the myometrium but without a full thickness perforation at the time of the uit, which in turn was potentially secondary to under-dilation of the endocervical canal at the time of device insertion.The disposable handpiece used in this case was not returned and therefore a failure analysis of the complaint device could not be performed.Device history was performed, the handpieces meet all qa specifications prior to being released, including adequate sterilization.The minerva es controller was returned and evaluated.Results of the evaluation indicated the controller passed the uit verification test and determined there was no device issue found and the controller/system operated as intended.Uterine perforations are known complications of an endometrial ablation procedure.Complications associated with perforations are addressed in the warning and caution sections 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.

Event Description

It was reported that six days after a minerva es endometrial ablation in-office procedure, the patient was admitted to the er with signs of acute abdomen.Ct was performed and free air was seen.Exploratory laparotomy, hysterectomy, bilateral salpingectomy, sigmoid colectomy with colostomy, cystoscopy (retrograde pyelogram - left) were performed.A uterine perforation was seen on a posterior wall of the uterus.After an uncomplicated post-operative course, the patient fully recovered and was discharged.

• Brand Name: MINERVA ES ENDOMETRIAL ABLATION DISPOSABLE HANDPIECE
• Type of Device: 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 becker ; 4255 burton drive; santa clara, CA 95054 ; 9787601704
• MDR Report Key: 17743806
• MDR Text Key: 323377964
• Report Number: 3011011193-2023-00025
• Device Sequence Number: 1
• Product Code: MNB
• UDI-Device Identifier: 00862393000162
• UDI-Public: 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: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MIN9770
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2023
• 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
• Patient Sex: Female