Mara Console GEN-16-050 (UDI 00857379006023)Recalls & reported problems
Aegea Medical Inc. · The Mara Console guides the physician through the procedure by use of a graphical user interface; regulates the creation of water vapor in the Water Vapor Probe; and provides automated real-time monitoring and active management throughout the procedure. · Class 3
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00857379006023), received between Jan 13, 2023 and Nov 9, 2023 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Abdominal Pain1
- Pneumoperitoneum1
- Unspecified Tissue Injury1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 9, 2023
ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOMETRIAL ABLATION WITH MARA WATER VAPOR ABLATION SYSTEM AND WAS DISCHARGED HOME THAT SAME DAY. ON (B)(6) 2023, SHE PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF SEVERE ABDOMINAL PAIN. A CT SCAN SHOWED PNEUMOPERITONEUM. SHE RETURNED TO THE OPERATING ROOM AT WHICH TIME IT WAS NOTED SHE HAD WHAT APPEARED TO BE A THERMAL INJURY TO HER UTERUS AND INTESTINES. SHE UNDERWENT TOTAL HYSTERECTOMY, BILATERAL SALPINGECTOMY, ILEOCECECTOMY WITH PRIMARY ANASTOMOSIS.
Patient problems: Abdominal Pain; Pneumoperitoneum; Unspecified Tissue Injury
MAUDE report 18118478 ↗MalfunctionJan 13, 2023Mechanical Problem; Mechanical Problem
INCIDENT DETAILS SURROUNDING EVENT. "WOULD NOT PASS PATENCY, NO MOVEMENT ON CONSOLE GAUGE" "PROCEDURE NOT COMPLETED." "IN-OFFICE UNDER GENERAL ANESTHESIA." "THE DR DECIDED TO RESCHEDULE HER PROCEDURE TO BE DONE IN THE OPERATING ROOM AT A LATER DATE." MARA CONSOLE GEN-16-050 E-COMPLAINT-(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16161561 ↗MalfunctionJan 13, 2023Mechanical Problem; Mechanical Problem
INCIDENT DETAILS SURROUNDING EVENT "WOULD NOT PASS PATENCY, NO MOVEMENT ON CONSOLE GAUGE" "PROCEDURE NOT COMPLETED." "IN-OFFICE UNDER GENERAL ANESTHESIA." "THE DR DECIDED TO RESCHEDULE HER PROCEDURE TO BE DONE IN THE OR AT A LATER DATE." MARA CONSOLE GEN-16-050 (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16159109 ↗MalfunctionJan 13, 2023Mechanical Problem; Mechanical Problem
HEALTHCARE PROFESSIONAL REPORTED VIA COMPANY REPRESENTATIVE "WOULD NOT PASS PATENCY, NO MOVEMENT ON CONSOLE GAUGE," AND THE PROCEDURE WAS NOT COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16159077 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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