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

Catalog Number	MIN9770
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bowel Burn (1756)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the limited information provided, a root cause cannot be determined.If additional information is obtained or received, minerva surgical will review and determine if supplemental report may be necessary.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 number was not provided by customer so device history review was not performed, the handpieces met all qa specifications prior to being released, including adequate sterilization.Uterine/bowel 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 or Problem Description
It was reported that a patient who received a minerva ablation procedure, unknown procedure date, had a bowel burn.The patient had a bowel resection and is reportedly doing well.The physician did not provide the original procedure date, the surgical intervention date, or any other information.The physician requested not to be contacted and would not provide additional information.

• Brand Name: MINERVA ENDOMETRIAL ABLATION SYSTEM, DISPOSABLE HANDPIECE
• Common Device Name: MINERVA 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: 19543881
• Report Number: 3011011193-2024-00011
• Device Sequence Number: 7606932
• Product Code: MNB
• UDI-Device Identifier: 00862393000162
• UDI-Public: 00862393000162
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2024

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: 05/20/2024
• Initial Report FDA Received Date: 06/15/2024
• 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: Required Intervention; Life Threatening
• Patient Sex: Female