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

Catalog Number MIN9770

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Bowel Burn (1756)

Event Date 10/20/2023

Event Type  Injury  

Manufacturer Narrative

This report is based upon information reported to minerva.Minerva has made multiple attempts to contact the parties involved in the reported case, however, was unsuccessful and unable to verify the details and/or validity of the reported event.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 directly associated with the adverse event.All handpieces meet all qa specifications prior to being released, including adequate sterilization.Thermal injuries are known complications of an endometrial ablation procedure.Complications associated with these injuries are addressed in the warning and caution sections of the operator's manual/instructions for use, including the statements: ·post-treatment, any patient-reporting signs/symptoms that could indicate a serious complication, e.G., bowel injury, should be thoroughly evaluated without delay.·careful measuring of the uterus is important for safe and proper minerva es disposable handpiece pfa length setting to prevent thermal injury to the endocervical canal.·if during the ablation cycle the cervical balloon does not adequately seal the cervical canal, unintended thermal damage to the endocervical canal may occur as a result of hot fluid leaking from the uterine cavity into the canal.Use clinical judgment to continue with the ablation procedure if such a leak is suspected.·patient with a uterine cavity length less than 4 cm.The minimum plasma formation array length is 4 cm.Treatment of a uterine cavity with a length less than 4 cm may result in thermal injury to the endocervical canal.Adverse event section includes: thermal injury to adjacent tissue, including bowel, bladder, cervix, vagina, vulva and/or perineum.Due to the limited information available and the subject device was not returned by customer, root cause could not be determined.Minerva surgical will continue to monitor complaint and if additional relevant information becomes available, a supplemental report will be submitted.

Event Description

It was reported that the patient experienced abdominal pain after an ablation procedure.The patient received a ct scan and was then transferred to general surgery.The nurse alleged there was a possible bowel burn; however, additional information was not disclosed.

• Brand Name: MINERVA ES ENDOMETRIAL ABLATION SYSTEM
• 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: 18187999
• MDR Text Key: 328737221
• Report Number: 3011011193-2023-00027
• 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: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• 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: 10/27/2023
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Female