MAUDE Adverse Event Report: MINERVA SURGICAL, INC. GENESYS HTA PROCERVA PROCEDURAL SET; ENDOMETRIIAL ABLATION SYSTEM

Catalog Number M006580210

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

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

Event Date 02/26/2023

Event Type  malfunction  

Manufacturer Narrative

No adverse events were reported.Upon receipt of complaint, the manufacturer was unable to determine whether an mdr was required based on the information contained in the initial report.It was not confirmed if the leaking occurred during setup with cooled saline or if it occurred during the ablation phase with heated saline.The manufacturer initiated a complaint investigation and obtained additional information.During the investigation, it was confirmed the procerva sheath tube had malfunctioned, potentially due to a failed component, which resulted in leaking of 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 tube is not designed to 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 is not available to be 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.

Event Description

It was reported that fluid was leaking at the distal end of the sheath component of the procerva procedural set and the procedure was aborted.No adverse event to the patient or user was reported.

• Brand Name: GENESYS HTA PROCERVA PROCEDURAL SET
• Type of Device: ENDOMETRIIAL 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: 16942602
• MDR Text Key: 315337321
• Report Number: 3011011193-2023-00016
• Device Sequence Number: 1
• Product Code: MNB
• 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: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M006580210
• Device Lot Number: 28749879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2022
• 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