MAUDE Adverse Event Report: MINERVA SURGICAL, INC. GENESYS HTA ENDOMETRIAL ABLATION SYSTEM

Model Number M006580210

Device Problems Fluid/Blood Leak (1250); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2023

Event Type  malfunction  

Event Description

It was reported that the proximal end of the sheath component of the procerva procedural set broke during use.No adverse event to the patient or user was reported.

Manufacturer Narrative

No adverse events were reported.It was reported the sheath broke during the cool down phase of the procedure, which resulted in leaking saline from the sheath.Although there is no reported adverse event, an mdr is being submitted as a malfunction report because it has been concluded that this device potentially failed to perform as intended.The sheath is not designed to break/leak during use.If this defect were to reoccur with heated saline, there is a potential for the device to cause or contribute to an adverse event (burn).The device has not been returned for evaluation.Therefore, failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.

• Brand Name: GENESYS HTA 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
• MDR Report Key: 16963753
• MDR Text Key: 315587212
• Report Number: 3011011193-2023-00017
• Device Sequence Number: 1
• Product Code: MNB
• UDI-Device Identifier: 08714729809456
• UDI-Public: 08714729809456
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2024
• Device Model Number: M006580210
• Device Catalogue Number: M006580210
• Device Lot Number: 29130754
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• 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 Sex: Female